Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT03332784

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

19.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1 narcolepsy.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants and Patients With Narcolepsy	Drug: TAK-925 Drug: Placebo	Phase 1

Detailed Description

Orexins are neuropeptides that play a role in the regulation of sleep and wakefulness. In type 1 narcolepsy, there is a loss of orexin producing neurons in the brain. The investigational drug, TAK-925, is an orexin 2 receptor agonist that is being tested in healthy adult participants, healthy elderly participants and patients with narcolepsy in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single intravenous administration.

The study will enroll approximately 20 healthy participants and 16 healthy elderly participants in Part 1 of the study and approximately 20 patients with narcolepsy in Part 2.

In Part 1, the study consists of 4 cohorts of 8 or 4 participants each. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups to receive TAK-925 or placebo:

Part 1, Cohort 1; TAK-925 (Dose Level 1, 3, 5), Cohort 2; TAK-925 (Dose Level 2, 4, 6), Cohort 3 and 4; TAK-925 (Dose Level 5)

For Cohort 1-4, healthy adult and elderly participants will be administered TAK-925 or placebo once in each cohort or dose level. The dose at the start (Cohort 1 dose level 1) is 7 mg of TAK-925 and following doses in Cohorts 1-4 will be determined based on available data from previous Cohorts/dose levels.

In Part 2 of the study, the study consists of 3 cohorts of 4 to 12 patients with narcolepsy. Patients will be randomly assigned to one of the treatment groups of Cohort 5-7 and will be administered TAK-925 or placebo once in each cohort. The dose of TAK-925 in Cohort 5-7 is TBD and will be decided based on available data from Part 1 and previous Cohorts.

Part 2, Cohort 5-7

This multi-center trial will be conducted in Japan. Participants will make multiple visits to the clinic. Visits in Part 1 will include a screening period (Day -28 to -2), Check-in on Day -1, Treatment period (Day 1 and 2), and follow-up visit on Day 7. In Part 2 of the study, the visits include a screening period (Day -42 to -2), Check-in on Day -1, Cross-over period (Day 1 to 4), and follow-up visit on Day 7.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

A Phase 1 Study of TAK-925 to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of TAK-925 in Healthy Adult and Elderly Volunteers and Patients With Narcolepsy

Actual Study Start Date :

Nov 4, 2017

Actual Primary Completion Date :

Sep 4, 2018

Actual Study Completion Date :

Sep 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: TAK-925 (Cohort 1; Dose Level 1) TAK-925, Intravenous single administration. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 2; Dose Level 2) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 2). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 1; Dose Level 3) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 3). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 2; Dose Level 4) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 4). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 1; Dose Level 5) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 2; Dose Level 6) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 6). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Placebo Comparator: Part 1: Placebo (Cohort 1-2) TAK-925 Placebo, Intravenous single administration. Healthy adults will be enrolled in double blind manner.	Drug: Placebo TAK-925 Placebo Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 3; Dose Level 5) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Healthy elderly participants will be enrolled in double blind manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Placebo Comparator: Part 1: Placebo (Cohort 3) TAK-925 Placebo, Intravenous single administration. Healthy elderly participants will be enrolled in double blind manner.	Drug: Placebo TAK-925 Placebo Intravenous Infusion
Experimental: Part 1: TAK-925 (Cohort 4; Dose Level 5) TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Healthy adults will be enrolled in non-blinded manner.	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 2: TAK-925 TBD (Cohort 5) TAK-925, Intravenous single administration. Dose in Cohort 5 will be based on safety and tolerability in the Part 1. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open).	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 2: TAK-925 TBD (Cohort 6) TAK-925, Intravenous single administration. Dose in Cohort 6 TBD based on safety, tolerability, PK data, and results of the Maintenance Wakefulness Test (MWT) from previous Cohorts. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open).	Drug: TAK-925 TAK-925 Intravenous Infusion
Experimental: Part 2: TAK-925 TBD (Cohort 7) TAK-925, Intravenous single administration. Dose in Cohort 7 TBD based on safety, tolerability, PK data, and results of the Maintenance of Wakefulness Test (MWT) from previous Cohorts. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open).	Drug: TAK-925 TAK-925 Intravenous Infusion
Placebo Comparator: Part 2: Placebo (Cohort 5-7) TAK-925 Placebo, Intravenous single administration. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open).	Drug: Placebo TAK-925 Placebo Intravenous Infusion

Outcome Measures

Primary Outcome Measures

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [Baseline up to Day 7]
Number of Participants Who Experience at Least One TEAE Related to Vital Signs [Baseline up to Day 7]
Number of Participants Who Experience at Least One TEAE Related to Body Weight [Baseline up to Day 7]
Number of Participants Who Experience at Least One TEAE Related to 12-lead Electrocardiogram (ECG) [Baseline up to Day 7]
Number of Participants Who Experience at Least One TEAE Related to Clinical Laboratory Tests [Baseline up to Day 7]
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, CL: Total Clearance After Intravenous Administration for TAK-925 [Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion]
Part 2, CL: Total Clearance After Intravenous Administration for TAK-925 [Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion]
Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24 [Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusion]
Urine assessments were done only in Part 1, as planned.
Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusion]
Urine assessments were done only in Part 1, as planned.
Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2 [Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6 and 6-15 hours post-infusion]
Urine assessments were done only in Part 1, as planned.
Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4 [Day 1 at 6 hours after start of infusion]

Secondary Outcome Measures

Part 2: Average Sleep Latency in Maintenance of Wakefulness Test (MWT) [Days 1 and 3 up to 8 hours following the start of infusion]
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adult participants and Healthy elderly participants:

Participant weighs at least 50 kilogram (kg) (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening.

Narcolepsy patients:

Patient weighs at least 40 kg inclusive at Screening.
A diagnosis of narcolepsy Type 1, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
HLA narcolepsy test positivity.
At Day -1, Epworth sleepiness scale (ESS) score greater than or equal to (>=) 10
Blood pressure less than (<) 140 systolic and < 90 diastolic. The patient may have a history of hypertension and be on antihypertensive medication treatment as long as the BP meets these criteria.

Exclusion Criteria:

All Participants:

Participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit.
Past or current epilepsy, convulsion, tremor or the disorders of related symptoms.
Has a lifetime history of major psychiatric disorder, such as major depressive disorder, bipolar disorder, or schizophrenia.

HV (only Cohort 4):

Participant has had CSF collection performed within 14 days prior to check-in (Day -1).

Narcolepsy patients

Medical disorder associated with excessive sleepiness other than narcolepsy (including sleep apnea syndrome).
Excessive caffeine (greater than [>] 400 milligram per day [mg/day]) use one week prior to study.

Contacts and Locations

Locations

	Site	City	State	Country
1	Sumida Hospital	Sumida-ku	Tokyo	Japan
2	Hakata Clinic	Fukuoka		Japan
3	PS Clinic	Fukuoka		Japan

Sponsors and Collaborators

Takeda

Investigators

Study Director: Study Director, Takeda

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT03332784

Other Study ID Numbers:

TAK-925-1001
U1111-1201-6634
JapicCTI-173756

First Posted:

Nov 6, 2017

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Narcolepsy

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 3 investigative sites in Japan from 04 November 2017 to 04 September 2018.
Pre-assignment Detail	Healthy adult and elderly participants were enrolled to receive TAK-925 or placebo in Cohorts 1 and 2 under alternating panel design and in Cohorts S1, S2, 3, and 4 under parallel design of Part 1, and participants with type 1 narcolepsy were enrolled to receive TAK-925 or placebo in a 2-period cross-over design in Cohorts 5, 6, and 7 of Part 2.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg	Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo	Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg	Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg	Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg	Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo	Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg	Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5: TAK-925 44.8 mg + Placebo	Part 2 Cohort 5: Placebo + TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg + Placebo	Part 2 Cohort 6: Placebo + TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg + Placebo	Part 2 Cohort 7: Placebo + TAK-925 5 mg
Arm/Group Description	TAK-925 7 milligram (mg), infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
Period Title: Parts 1 and 2 - Period 1 (1 Day)
STARTED	2	2	2	2	2	2	2	2	4	6	6	2	6	4	2	2	2	2	3	3
COMPLETED	2	1	2	2	2	2	2	2	4	6	6	2	6	4	1	2	2	2	3	3
NOT COMPLETED	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Period Title: Parts 1 and 2 - Period 1 (1 Day)
STARTED	2	1	2	2	2	2	2	2	0	0	0	0	0	0	1	2	2	2	3	3
COMPLETED	2	1	2	2	2	2	2	2	0	0	0	0	0	0	1	2	2	2	3	3
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Parts 1 and 2 - Period 1 (1 Day)
STARTED	2	1	2	2	2	2	2	2	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	2	1	2	2	2	2	2	2	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg	Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo	Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg	Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg	Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg	Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo	Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg	Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1: Cohort S1 TAK-925 180 mg	Part 1: Cohort S2 TAK-925 240 mg	Part 1: Cohort 3 Placebo	Part 1: Cohort 3 TAK-925 112 mg	Part 1: Cohort 4 TAK-925 112 mg	Part 2 Cohort 5: TAK-925 44.8 mg + Placebo	Part 2 Cohort 5, Part J: TAK-925 Placebo + 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg + Placebo	Part 2 Cohort 6: Placebo + TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg + Placebo	Part 2 Cohort 7: Placebo + TAK-925 5 mg	Total
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in unblinded manner.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications	Total of all reporting groups
Overall Participants	2	2	2	2	2	2	2	2	4	6	6	2	6	4	2	2	2	2	3	3	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.0 (5.66)	25.5 (4.95)	22.0 (2.83)	30.0 (4.24)	24.5 (3.54)	28.0 (9.90)	28.5 (9.19)	34.5 (4.95)	24.8 (4.57)	24.5 (5.75)	27.5 (6.72)	72.5 (3.54)	67.7 (2.94)	21.3 (0.50)	21.5 (4.95)	33.0 (15.56)	25.5 (7.78)	38.5 (0.71)	42.3 (20.11)	33.7 (4.51)	33.7 (16.26)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 50%	3 50%	0 0%	2 100%	0 0%	0 0%	2 100%	3 100%	1 33.3%	12 20.7%
Male	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	4 100%	6 100%	6 100%	1 50%	3 50%	4 100%	0 0%	2 100%	2 100%	0 0%	0 0%	2 66.7%	46 79.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Japan	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	2 100%	4 100%	6 100%	6 100%	2 100%	6 100%	4 100%	2 100%	2 100%	2 100%	2 100%	3 100%	3 100%	58 100%
Body Mass Index (BMI) (kilogram per square meter (kg/m˄2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter (kg/m˄2)]	22.25 (2.475)	22.35 (0.919)	20.85 (2.899)	22.10 (0.141)	21.55 (2.616)	20.90 (0.424)	23.40 (2.687)	22.15 (1.626)	22.65 (1.912)	20.48 (0.768)	21.05 (1.325)	23.00 (2.263)	23.22 (3.451)	22.03 (2.791)	32.30 (10.041)	24.60 (2.546)	23.60 (0.707)	26.45 (8.697)	26.10 (7.146)	29.57 (5.689)	23.19 (4.072)
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	176.0 (1.41)	167.0 (2.83)	174.5 (2.12)	177.0 (8.49)	170.0 (4.24)	173.0 (1.41)	170.0 (9.90)	171.5 (6.36)	173.5 (5.80)	173.0 (3.16)	168.8 (5.00)	149.0 (0.00)	159.5 (4.64)	171.0 (5.89)	155.5 (0.71)	174.5 (6.36)	171.0 (1.41)	159.5 (2.12)	160.7 (4.73)	168.3 (11.55)	168.1 (8.11)
Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]	68.15 (7.707)	62.65 (0.636)	62.90 (10.607)	69.60 (6.930)	60.95 (5.445)	62.45 (1.909)	68.80 (14.849)	63.85 (8.839)	68.73 (1.941)	61.12 (2.860)	59.55 (6.142)	51.30 (4.101)	58.77 (10.388)	63.88 (7.029)	78.45 (24.112)	74.95 (0.071)	69.05 (1.202)	67.70 (23.900)	67.57 (22.212)	83.43 (15.970)	65.20 (10.994)
Smoking Classification (Count of Participants)
Non-smoker	2 100%	2 100%	2 100%	2 100%	1 50%	1 50%	2 100%	1 50%	2 50%	5 83.3%	5 83.3%	2 100%	6 100%	3 75%	2 100%	1 50%	1 50%	1 50%	2 66.7%	1 33.3%	44 75.9%
Current smoker	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 50%	1 33.3%	1 33.3%	3 5.2%
Former smoker	0 0%	0 0%	0 0%	0 0%	1 50%	1 50%	0 0%	1 50%	2 50%	1 16.7%	1 16.7%	0 0%	0 0%	1 25%	0 0%	1 50%	1 50%	0 0%	0 0%	1 33.3%	11 19%
Alcohol Classification (Count of Participants)
Daily	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 50%	0 0%	0 0%	1 1.7%
A Few Times Per Week	1 50%	1 50%	0 0%	0 0%	1 50%	0 0%	1 50%	2 100%	0 0%	0 0%	0 0%	1 50%	1 16.7%	0 0%	0 0%	0 0%	1 50%	0 0%	0 0%	1 33.3%	10 17.2%
A Few Times Per Month	1 50%	0 0%	1 50%	1 50%	0 0%	1 50%	0 0%	0 0%	4 100%	3 50%	4 66.7%	0 0%	2 33.3%	3 75%	1 50%	1 50%	1 50%	0 0%	2 66.7%	0 0%	25 43.1%
Non-alcoholic	0 0%	1 50%	1 50%	1 50%	1 50%	1 50%	1 50%	0 0%	0 0%	3 50%	2 33.3%	1 50%	3 50%	1 25%	1 50%	1 50%	0 0%	1 50%	1 33.3%	2 66.7%	22 37.9%
Caffeine Classification (Count of Participants)
Had caffeine consumption	2 100%	0 0%	0 0%	2 100%	0 0%	1 50%	1 50%	1 50%	1 25%	3 50%	3 50%	1 50%	5 83.3%	3 75%	2 100%	2 100%	2 100%	2 100%	1 33.3%	3 100%	35 60.3%
Had no caffeine consumption	0 0%	2 100%	2 100%	0 0%	2 100%	1 50%	1 50%	1 50%	3 75%	3 50%	3 50%	1 50%	1 16.7%	1 25%	0 0%	0 0%	0 0%	0 0%	2 66.7%	0 0%	23 39.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Description
Time Frame	Baseline up to Day 7

Outcome Measure Data

Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	11	6	6	5	6	6	6	4	6	6	2	6	4	13	4	4	6
Count of Participants [Participants]	1 50%	1 50%	1 50%	1 50%	1 50%	1 50%	2 100%	1 50%	3 75%	5 83.3%	0 0%	3 150%	1 16.7%	0 0%	4 200%	1 50%	0 0%

2. Primary Outcome

Title	Number of Participants Who Experience at Least One TEAE Related to Vital Signs
Description
Time Frame	Baseline up to Day 7

Outcome Measure Data

Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	11	6	6	5	6	6	6	4	6	6	2	6	4	13	4	4	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 100%	0 0%	2 50%	4 66.7%	0 0%	3 150%	0 0%	0 0%	1 50%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants Who Experience at Least One TEAE Related to Body Weight
Description
Time Frame	Baseline up to Day 7

Outcome Measure Data

Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	11	6	6	5	6	6	6	4	6	6	2	6	4	13	4	4	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Who Experience at Least One TEAE Related to 12-lead Electrocardiogram (ECG)
Description
Time Frame	Baseline up to Day 7

Outcome Measure Data

Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	11	6	6	5	6	6	6	4	6	6	2	6	4	13	4	4	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	1 50%	0 0%	1 50%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants Who Experience at Least One TEAE Related to Clinical Laboratory Tests
Description
Time Frame	Baseline up to Day 7

Outcome Measure Data

Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1-S2: Pooled Placebo	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: Placebo	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	11	6	6	5	6	6	6	4	6	6	2	6	4	13	4	4	6
Count of Participants [Participants]	1 50%	0 0%	0 0%	0 0%	1 50%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or cerebrospinal fluid (CSF) concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	138.0 (22.546)	323.1 (45.793)	513.3 (81.392)	1055 (178.49)	2069 (298.89)	2655 (495.32)	2994 (164.73)	4542 (698.25)	2546 (274.48)	2011 (195.00)
Metabolite M1	74.10 (31.837)	170.7 (50.607)	293.1 (120.91)	613.8 (218.79)	1272 (409.93)	1724 (596.04)	1762 (204.30)	3094 (740.81)	1037 (343.80)	996.3 (321.79)
Metabolite M2	0.3676 (0.89268)	1.940 (2.5750)	5.893 (2.8201)	9.225 (6.3231)	22.79 (19.464)	31.23 (25.058)	28.69 (4.9460)	56.79 (21.993)	15.96 (9.4609)	16.81 (8.7980)

7. Primary Outcome

Title	Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	910.8 (275.10)	198.7 (13.540)	86.15 (14.777)
Metabolite M1	623.6 (516.16)	100.7 (55.904)	52.25 (17.041)
Metabolite M2	10.90 (22.384)	3.435 (2.0430)

8. Primary Outcome

Title	Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	141.8 (22.744)	328.1 (51.138)	523.5 (88.288)	1065 (187.70)	2092 (319.85)	2682 (519.45)	3013 (160.21)	4585 (689.28)	2590 (283.03)	2028 (196.21)
Metabolite M1	75.77 (32.409)	173.5 (53.475)	296.1 (122.50)	618.9 (221.98)	1284 (409.94)	1737 (606.78)	1764 (202.65)	3112 (745.48)	1052 (350.05)	1001 (323.04)
Metabolite M2	2.900	5.302 (1.6898)	6.416 (1.0512)	9.796 (6.6369)	23.79 (19.535)	32.29 (25.766)	29.43 (5.0744)	57.72 (21.853)	16.88 (9.9205)	17.22 (8.8861)

9. Primary Outcome

Title	Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	925.3 (296.03)	200.7 (13.216)	88.45 (13.682)
Metabolite M1	634.0 (549.20)	102.4 (55.929)	54.77 (17.148)
Metabolite M2	27.99 (28.284)	3.816 (0.60811)

10. Primary Outcome

Title	Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	16.70 (2.8896)	36.83 (4.3976)	57.56 (8.2309)	122.6 (13.014)	235.2 (40.712)	304.9 (50.702)	344.5 (23.549)	506.3 (87.027)	278.4 (33.127)	237.8 (25.695)
Metabolite M1	8.458 (3.5972)	19.50 (4.9426)	31.82 (11.983)	67.69 (20.931)	134.1 (45.828)	189.2 (60.185)	197.8 (26.011)	333.2 (70.509)	106.7 (30.612)	114.4 (38.575)
Metabolite M2	0.2379 (0.11806)	0.4290 (0.24813)	0.7051 (0.33672)	1.076 (0.63619)	2.564 (2.0370)	3.422 (2.4880)	3.279 (0.53902)	6.611 (2.2350)	1.751 (0.90125)	2.022 (0.99882)

11. Primary Outcome

Title	Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	96.48 (21.981)	21.86 (2.5303)	10.10 (1.9527)
Metabolite M1	64.28 (39.990)	11.23 (5.0467)	5.990 (1.8931)
Metabolite M2	1.305 (1.9483)	0.4884 (0.28306)

12. Primary Outcome

Title	Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	13.37 (2.0174)	29.81 (4.2579)	52.08 (7.2344)	114.6 (13.303)	213.8 (31.714)	290.3 (32.096)	324.0 (30.182)	493.2 (70.335)	272.2 (36.985)	183.5 (15.875)
Metabolite M1	7.532 (3.4019)	17.79 (4.9179)	28.06 (11.208)	58.79 (23.607)	121.3 (37.632)	167.5 (58.242)	174.0 (20.376)	295.5 (75.002)	98.82 (31.862)	105.0 (38.567)
Metabolite M2	0.2289 (0.12885)	0.3978 (0.23853)	0.5928 (0.27538)	0.9225 (0.54081)	2.217 (1.6608)	3.079 (2.3329)	2.850 (0.52592)	4.868 (2.3897)	1.528 (0.87452)	1.624 (0.96722)

13. Primary Outcome

Title	Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	94.04 (23.643)	21.17 (1.7896)	9.649 (1.1339)
Metabolite M1	58.61 (42.471)	9.916 (5.6434)	5.412 (1.7517)
Metabolite M2	1.075 (1.8500)	0.4037 (0.23357)

14. Primary Outcome

Title	Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	3.000	4.000	3.000	4.000	4.000	6.500	6.500	4.000	6.500	5.000
Metabolite M1	6.000	6.000	6.000	6.000	6.000	6.000	6.000	6.000	6.000	8.000
Metabolite M2	7.500	8.000	4.000	6.000	4.000	4.000	5.000	3.500	3.000	3.500

15. Primary Outcome

Title	Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	6.500	9.000	9.000
Metabolite M1	6.000	6.000	6.000
Metabolite M2	5.960	5.990

16. Primary Outcome

Title	Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	4.120 (1.9190)	4.498 (1.7725)	5.142 (1.8060)	3.860 (0.6478)	3.788 (1.0424)	3.943 (0.9492)	3.363 (0.8523)	4.033 (1.2843)	4.345 (0.5901)	4.490 (1.5939)
Metabolite M1	2.598 (1.3239)	3.443 (0.9386)	3.122 (0.4673)	2.760 (0.8950)	3.075 (0.5984)	2.825 (0.5203)	2.205 (0.2616)	2.637 (0.5575)	3.763 (0.7675)	2.400 (0.6307)
Metabolite M2	2.670	1.8975 (0.2583)	1.545 (0.1237)	1.692 (0.7082)	2.158 (0.7646)	2.847 (1.5995)	1.702 (0.4891)	2.818 (1.0856)	2.727 (1.3977)	1.205 (0.2873)

17. Primary Outcome

Title	Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	6
TAK-925	4.130 (1.1981)	3.923 (1.0265)	3.465 (1.0998)
Metabolite M1	3.670 (0.9131)	2.523 (1.0892)	2.154 (0.4215)
Metabolite M2	4.120 (2.5032)	0.915 (0.2192)

18. Primary Outcome

Title	Part 1, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	5	6	5	6	6	6	6	6	6	4
Mean (Standard Deviation) [liter]	82.88 (29.543)	77.07 (22.804)	116.1 (35.215)	91.40 (14.122)	97.83 (22.194)	88.47 (12.476)	90.75 (24.140)	97.48 (28.378)	99.48 (15.472)	77.98 (28.931)

19. Primary Outcome

Title	Part 2, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	4
Mean (Standard Deviation) [liter]	116.8 (7.8049)	114.1 (14.964)	111.7 (26.464)

20. Primary Outcome

Title	Part 1, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	5	6	5	6	6	6	6	6	6	4
Mean (Standard Deviation) [liter]	292.2 (124.03)	271.7 (79.238)	391.8 (117.09)	290.7 (31.156)	288.8 (55.185)	284.7 (65.265)	290.8 (77.783)	313.0 (128.81)	271.5 (39.145)	357.3 (121.15)

21. Primary Outcome

Title	Part 2, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	4
Mean (Standard Deviation) [liter]	281.3 (35.855)	316.8 (84.263)	282.3 (88.729)

22. Primary Outcome

Title	Part 1, CL: Total Clearance After Intravenous Administration for TAK-925
Description
Time Frame	Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	5	6	5	6	6	6	6	6	6	4
Mean (Standard Deviation) [liter per hour (L/h)]	50.00 (9.0785)	43.07 (6.4856)	54.20 (9.9541)	53.10 (8.2202)	54.10 (9.0437)	50.90 (9.8018)	59.83 (3.3381)	52.78 (7.4882)	43.50 (4.9651)	55.40 (5.2211)

23. Primary Outcome

Title	Part 2, CL: Total Clearance After Intravenous Administration for TAK-925
Description
Time Frame	Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	4	4	4
Mean (Standard Deviation) [L/h]	50.18 (15.533)	55.90 (3.7692)	57.05 (9.5577)

24. Primary Outcome

Title	Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24
Description	Urine assessments were done only in Part 1, as planned.
Time Frame	Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	5	6	5	6	6	6	6	6	6	4
TAK-925	1.892 (0.93889)	5.460 (3.4291)	14.10 (2.4515)	60.87 (23.008)	210.5 (75.775)	335.8 (117.81)	578.5 (110.30)	1223 (76.855)	214.3 (137.61)	184.8 (53.662)
Metabolite M1	198.8 (49.600)	426.7 (101.25)	792.8 (253.36)	1697 (495.32)	1905 (1490.9)	5228 (1785.9)	5815 (1095.4)	8163 (945.57)	2343 (635.69)	3193 (677.37)
Metabolite M2	0.000 (0.0000)	1.152 (1.5202)	2.438 (2.2612)	8.695 (5.3533)	31.25 (26.282)	40.08 (28.904)	43.12 (8.4203)	79.90 (23.679)	14.37 (6.0079)	21.01 (10.331)

25. Primary Outcome

Title	Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2
Description	Urine assessments were done only in Part 1, as planned.
Time Frame	Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	5	6	5	6	6	6	6	6	6	4
TAK-925	0.028 (0.0148)	0.038 (0.0232)	0.050 (0.0071)	0.110 (0.0424)	0.190 (0.0657)	0.250 (0.0883)	0.322 (0.0624)	0.508 (0.0319)	0.192 (0.1237)	0.165 (0.0480)
Metabolite M1	2.736 (0.6841)	2.938 (0.6950)	2.726 (0.8677)	2.920 (0.8519)	3.358 (1.2922)	3.748 (1.2809)	3.112 (0.5872)	3.280 (0.3788)	2.015 (0.5452)	2.748 (0.5871)
Metabolite M2	0.000 (0.0000)	0.008 (0.0117)	0.008 (0.0084)	0.017 (0.0103)	0.025 (0.0243)	0.028 (0.0214)	0.023 (0.0052)	0.032 (0.0117)	0.013 (0.0082)	0.018 (0.0096)

26. Primary Outcome

Title	Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2
Description	Urine assessments were done only in Part 1, as planned.
Time Frame	Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6 and 6-15 hours post-infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.

Arm/Group Title	Part 1 Cohort 1: TAK-925 7 mg	Part 1 Cohort 2: TAK-925 14 mg	Part 1 Cohort 1: TAK-925 28 mg	Par 1 Cohort 2: TAK-925 56 mg	Part 1 Cohort 1: TAK-925 112 mg	Part 1 Cohort 2: TAK-925 134.4 mg	Part 1 Cohort S1: TAK-925 180 mg	Part 1 Cohort S2: TAK-925 240 mg	Part 1 Cohort 3: TAK-925 112 mg	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.	TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.	TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	6	6	5	6	6	6	6	6	6	4
TAK-925	0.01390 (0.0071503)	0.01656 (0.0097578)	0.02746 (0.0053337)	0.05672 (0.018842)	0.1020 (0.037350)	0.1275 (0.046864)	0.1928 (0.035244)	0.2705 (0.031501)	0.08337 (0.053779)	0.09053 (0.018093)
Metabolite M1	2.664 (0.83930)	2.438 (0.30142)	2.614 (0.54500)	2.653 (0.24138)	2.952 (0.65615)	2.878 (0.35459)	3.285 (0.49152)	2.643 (0.37012)	2.205 (0.35172)	3.173 (0.50684)
Metabolite M2	0.000 (0.0000)	0.2182 (0.25950)	0.4630 (0.31605)	0.7897 (0.077544)	1.014 (0.23516)	1.041 (0.12104)	1.468 (0.20508)	1.353 (0.12894)	0.7967 (0.15368)	1.132 (0.24401)

27. Primary Outcome

Title	Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4
Description
Time Frame	Day 1 at 6 hours after start of infusion

Outcome Measure Data

Analysis Population Description
The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated.

Arm/Group Title	Part 1 Cohort 4: TAK-925 112 mg
Arm/Group Description	TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
Measure Participants	4
TAK-925	0.02848 (0.0056258)
Metabolite M1	0.06190 (0.010358)
Metabolite M2	0.02818 (0.032718)

28. Secondary Outcome

Title	Part 2: Average Sleep Latency in Maintenance of Wakefulness Test (MWT)
Description	The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Time Frame	Days 1 and 3 up to 8 hours following the start of infusion

Outcome Measure Data

Analysis Population Description
The pharmacodynamic analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Part 2 Cohort 5-7: Pooled Placebo	Part 2 Cohort 5: TAK-925 44.8 mg	Part 2 Cohort 6: TAK-925 11.2 mg	Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.	TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.	TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
Measure Participants	13	4	4	6
Mean (Standard Deviation) [minutes]	2.88 (1.646)	40.00 (0.000)	37.59 (4.813)	22.38 (10.125)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1 Cohort 1-2: Pooled Placebo, Part 1 Cohort 1: TAK-925 7 mg
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Part 1 Cohort 1-2: Pooled Placebo, Part 1 Cohort 2: TAK-925 14 mg
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Part 1 Cohort 1-2: Pooled Placebo, Part 1 Cohort 1: TAK-925 28 mg
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.
	Method	ANOVA
	Comments

Adverse Events

	Part 1 Cohort 1-2: Pooled Placebo		Part 1 Cohort 1: TAK-925 7 mg		Part 1 Cohort 2: TAK-925 14 mg		Part 1 Cohort 1: TAK-925 28 mg		Par 1 Cohort 2: TAK-925 56 mg		Part 1 Cohort 1: TAK-925 112 mg		Part 1 Cohort 2: TAK-925 134.4 mg		Part 1 Cohort S1-S2: Pooled Placebo		Part 1 Cohort S1: TAK-925 180 mg		Part 1 Cohort S2: TAK-925 240 mg		Part 1 Cohort 3: Placebo		Part 1 Cohort 3: TAK-925 112 mg		Part 1 Cohort 4: TAK-925 112 mg		Part 2 Cohort 5-7: Pooled Placebo		Part 2 Cohort 5: TAK-925 44.8 mg		Part 2 Cohort 6: TAK-925 11.2 mg		Part 2 Cohort 7: TAK-925 5 mg
Time Frame	Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Arm/Group Title	Part 1 Cohort 1-2: Pooled Placebo		Part 1 Cohort 1: TAK-925 7 mg		Part 1 Cohort 2: TAK-925 14 mg		Part 1 Cohort 1: TAK-925 28 mg		Par 1 Cohort 2: TAK-925 56 mg		Part 1 Cohort 1: TAK-925 112 mg		Part 1 Cohort 2: TAK-925 134.4 mg		Part 1 Cohort S1-S2: Pooled Placebo		Part 1 Cohort S1: TAK-925 180 mg		Part 1 Cohort S2: TAK-925 240 mg		Part 1 Cohort 3: Placebo		Part 1 Cohort 3: TAK-925 112 mg		Part 1 Cohort 4: TAK-925 112 mg		Part 2 Cohort 5-7: Pooled Placebo		Part 2 Cohort 5: TAK-925 44.8 mg		Part 2 Cohort 6: TAK-925 11.2 mg		Part 2 Cohort 7: TAK-925 5 mg
Arm/Group Description	TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.		TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.		TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.		TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.		TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.		TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.		TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.		TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.		TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.		TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.		TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.		TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.		TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.		TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.		TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.		TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.		TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Serious Adverse Events
	Part 1 Cohort 1-2: Pooled Placebo		Part 1 Cohort 1: TAK-925 7 mg		Part 1 Cohort 2: TAK-925 14 mg		Part 1 Cohort 1: TAK-925 28 mg		Par 1 Cohort 2: TAK-925 56 mg		Part 1 Cohort 1: TAK-925 112 mg		Part 1 Cohort 2: TAK-925 134.4 mg		Part 1 Cohort S1-S2: Pooled Placebo		Part 1 Cohort S1: TAK-925 180 mg		Part 1 Cohort S2: TAK-925 240 mg		Part 1 Cohort 3: Placebo		Part 1 Cohort 3: TAK-925 112 mg		Part 1 Cohort 4: TAK-925 112 mg		Part 2 Cohort 5-7: Pooled Placebo		Part 2 Cohort 5: TAK-925 44.8 mg		Part 2 Cohort 6: TAK-925 11.2 mg		Part 2 Cohort 7: TAK-925 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Part 1 Cohort 1-2: Pooled Placebo		Part 1 Cohort 1: TAK-925 7 mg		Part 1 Cohort 2: TAK-925 14 mg		Part 1 Cohort 1: TAK-925 28 mg		Par 1 Cohort 2: TAK-925 56 mg		Part 1 Cohort 1: TAK-925 112 mg		Part 1 Cohort 2: TAK-925 134.4 mg		Part 1 Cohort S1-S2: Pooled Placebo		Part 1 Cohort S1: TAK-925 180 mg		Part 1 Cohort S2: TAK-925 240 mg		Part 1 Cohort 3: Placebo		Part 1 Cohort 3: TAK-925 112 mg		Part 1 Cohort 4: TAK-925 112 mg		Part 2 Cohort 5-7: Pooled Placebo		Part 2 Cohort 5: TAK-925 44.8 mg		Part 2 Cohort 6: TAK-925 11.2 mg		Part 2 Cohort 7: TAK-925 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		1/6 (16.7%)		1/6 (16.7%)		1/5 (20%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		1/4 (25%)		3/6 (50%)		5/6 (83.3%)		0/2 (0%)		3/6 (50%)		1/4 (25%)		0/13 (0%)		4/4 (100%)		1/4 (25%)		0/6 (0%)
Gastrointestinal disorders
Nausea	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Salivary hypersecretion	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
General disorders
Feeling drunk	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Infections and infestations
Influenza	0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Nasopharyngitis	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		1/6 (16.7%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Pharyngitis	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Investigations
Blood pressure increased	1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		0/4 (0%)		2/6 (33.3%)		4/6 (66.7%)		0/2 (0%)		3/6 (50%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Electrocardiogram PR prolongation	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		2/6 (33.3%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Heart rate increased	0/11 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Blood triglycerides increased	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
White blood cell count increased	1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
C-reactive protein increased	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		1/6 (16.7%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		1/4 (25%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Nervous system disorders
Dizziness	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		1/6 (16.7%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Narcolepsy	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		1/4 (25%)		0/6 (0%)
Psychiatric disorders
Euphoric mood	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Hypnagogic hallucination	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Logorrhoea	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)
Cough	0/11 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/4 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		1/4 (25%)		0/4 (0%)		0/6 (0%)
Vascular disorders
Orthostatic hypotension	0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/4 (25%)		1/6 (16.7%)		0/6 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/13 (0%)		0/4 (0%)		0/4 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.

Results Point of Contact

Name/Title	Medical Director
Organization	Takeda
Phone	+1-877-825-3327
Email	trialdisclosures@takeda.com

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT03332784

Other Study ID Numbers:

TAK-925-1001
U1111-1201-6634
JapicCTI-173756

First Posted:

Nov 6, 2017

Last Update Posted:

Mar 30, 2021

Last Verified:

Mar 1, 2021

Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Healthy adult participants and Healthy elderly participants:

Narcolepsy patients:

Exclusion Criteria:

All Participants:

HV (only Cohort 4):

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact