A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

• Sponsor: Neurocrine Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04234672
• Collaborator: Takeda (Industry)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: TAK-831 Oral Tablet; Drug: [14C]TAK-831 IV Infusion; Drug: [14C]TAK-831 Oral Suspension	Phase 1

Detailed Description

The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-831 after single oral administration in Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.

The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and elimination [ADME] study period). In Period 1 (ABA study period), all participants will receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects
• Actual Study Start Date: Feb 17, 2020
• Actual Primary Completion Date: Apr 4, 2020
• Actual Study Completion Date: Apr 4, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg TAK-831 500 mg, tablet, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.

Drug: TAK-831 Oral Tablet; TAK-831 tablet.; Other Names: Luvadaxistat ; Drug: [14C]TAK-831 IV Infusion; [14C]TAK-831 IV infusion.; Drug: [14C]TAK-831 Oral Suspension; [14C]TAK-831 oral suspension.

Outcome Measures

Primary Outcome Measures

1. Period 1: Percent Absolute Bioavailability (%F) for TAK-831 [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

   Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.

2. Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose] [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

3. Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

4. Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR]) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

5. Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe]) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

6. Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose]

7. Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

8. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

9. Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

10. Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831 [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

11. Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

12. Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

13. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

14. Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

15. Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

16. Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

17. Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax) [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

18. Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

19. Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

20. Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2]

21. Period 2: CLR: Renal Clearance for TAK-831 in Urine [Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose]

Secondary Outcome Measures

1. Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831 [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

2. Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

3. Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

4. Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

5. Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

6. Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration [Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1]

7. Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration [Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1]

8. Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma [Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose]

9. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)]

   An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.

10. Number of Participants With TEAEs Related to Electrocardiogram (ECG) [Up to Day 14]

    The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).

11. Number of Participants With TEAEs Related to Vital Signs [Up to Day 14]

    Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.

12. Number of Participants With TEAEs Related to Laboratory Parameters [Up to Day 14]

    The laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Weighs at least 45 kilogram (kg) and body mass index (BMI) greater than or equal to (>=) 18.0 and less than (˂) 32.0 kilogram per square meter (kg/m^2) at screening.

Exclusion Criteria:

1. Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.

2. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.

3. Estimated creatinine clearance <80 milliliter per minute (mL/min) at screening.

4. Has tattoo(s) or scarring at or near the site of intravenous infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.

5. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.

6. Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe (that is weighted annual limit recommended by the International Commission on Radiological Protection [ICRP] of 3000 milli roentgen equivalent man [mrem]).

7. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.

8. Donation of blood or significant blood loss within 56 days prior to the first dosing.

9. Plasma donation within 7 days prior to the first dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Neurocrine Biosciences
• Takeda

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 29, 2019
• Statistical Analysis Plan - Apr 16, 2020

More Information

Publications

None provided.

• Responsible Party: Neurocrine Biosciences
• ClinicalTrials.gov Identifier: NCT04234672
• Other Study ID Numbers: TAK-831-1008; U1111-1242-9877
• First Posted: Jan 21, 2020
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Neurocrine Biosciences: Drug Therapy

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 1 investigative site in the United States from 17 Feb 2020 to 04 April 2020.
Pre-assignment Detail	Healthy male participants were enrolled in this study to receive TAK-831 tablets followed by radio-labelled TAK-831 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-831 oral suspension on Day 1 of Treatment Period 2. There was an 8-day washout period between the two periods.

Arm/Group Title	TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg
Arm/Group Description	TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
Period Title: Treatment Period 1 (Day 1)
STARTED	6
COMPLETED	6
NOT COMPLETED	0
Period Title: Treatment Period 1 (Day 1)
STARTED	6
COMPLETED	6
NOT COMPLETED	0
Period Title: Treatment Period 1 (Day 1)
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg
Arm/Group Description	TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by [14C]TAK-831 50 micrograms (μg) [approximately 1 microcurie (μCi)], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by [14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
Overall Participants	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.2 (6.9)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 50%
Not Hispanic or Latino	3 50%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 33.3%
White	3 50%
More than one race	1 16.7%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	174.8 (6.1)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	80.25 (6.5)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.28 (1.6)

Outcome Measures

1. Primary Outcome

Title	Period 1: Percent Absolute Bioavailability (%F) for TAK-831
Description	Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg + [14C]TAK-831 50 μg
Arm/Group Description	TAK-831 5 X 100 mg tablets, orally, followed by [14C]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [percent absolute bioavailability]	17.34 (31.3)

2. Primary Outcome

Title	Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]	88.66 (3.6)

3. Primary Outcome

Title	Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [mg equivalents (eq) of parent drug]	472.7 (3.3)

4. Primary Outcome

Title	Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]	27.50 (19.8)

5. Primary Outcome

Title	Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [percentage of dose]	60.71 (5.9)

6. Primary Outcome

Title	Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	1243 (33.2)

7. Primary Outcome

Title	Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Median (Full Range) [hours (hr)]	0.799

8. Primary Outcome

Title	Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Mean (Standard Deviation) [hr]	10.314 (6.3900)

9. Primary Outcome

Title	Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	4198 (30.8)

10. Primary Outcome

Title	Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	4171 (30.8)

11. Primary Outcome

Title	Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq/mL]	5878 (11.4)

12. Primary Outcome

Title	Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Median (Full Range) [hr]	2.005

13. Primary Outcome

Title	Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Mean (Standard Deviation) [hr]	3.162 (0.3068)

14. Primary Outcome

Title	Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/mL]	31010 (9.8)

15. Primary Outcome

Title	Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/mL]	28860 (8.8)

16. Primary Outcome

Title	Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq/g]	2881 (9.2)

17. Primary Outcome

Title	Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Median (Full Range) [hr]	2.001

18. Primary Outcome

Title	Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Mean (Standard Deviation) [hr]	2.580 (0.3922)

19. Primary Outcome

Title	Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/g]	15180 (13.7)

20. Primary Outcome

Title	Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng eq*hr/g]	13420 (14.2)

21. Primary Outcome

Title	Period 2: CLR: Renal Clearance for TAK-831 in Urine
Time Frame	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of [14C]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 500 mg
Arm/Group Description	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [L/hr]	0.06547 (38.6)

22. Secondary Outcome

Title	Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831
Time Frame	Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 μg IV infusion in Period 1 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 50 μg
Arm/Group Description	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [picograms per milliliter (pg/mL)]	2903 (26.7)

23. Secondary Outcome

Title	Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	1121 (45.5)

24. Secondary Outcome

Title	Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
Measure Participants	6
Median (Full Range) [hr]	1.255

25. Secondary Outcome

Title	Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [nanogram hour/milliliter (ng*hr/mL)]	3436 (45.7)

26. Secondary Outcome

Title	Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 50 μg
Arm/Group Description	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [pg*hr/mL]	1992 (18.1)

27. Secondary Outcome

Title	Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	3397 (46.6)

28. Secondary Outcome

Title	Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration
Time Frame	Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	[14C]TAK-831 50 μg
Arm/Group Description	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
Measure Participants	6
Geometric Mean (Geometric Coefficient of Variation) [pg*hr/mL]	1972 (18.1)

29. Secondary Outcome

Title	Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma
Time Frame	Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose

Outcome Measure Data

Analysis Population Description

PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and [14C]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Arm/Group Title	TAK-831 500 mg	[14C]TAK-831 50 μg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.
Measure Participants	6	6
Mean (Standard Deviation) [hr]	12.278 (6.0291)	3.815 (1.0456)

30. Secondary Outcome

Title	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Description	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Time Frame	From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least one dose of the study drug. Data is reported as per the treatment received in Treatment Periods 1 and 2.

Arm/Group Title	TAK-831 500 mg	[14C]TAK-831 50 μg	[14C]TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6	6	6
Count of Participants [Participants]	0 0%	0 NaN	2 NaN

31. Secondary Outcome

Title	Number of Participants With TEAEs Related to Electrocardiogram (ECG)
Description	The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

Arm/Group Title	TAK-831 500 mg	[14C]TAK-831 50 μg	[14C]TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6	6	6
Count of Participants [Participants]	0 0%	0 NaN	0 NaN

32. Secondary Outcome

Title	Number of Participants With TEAEs Related to Vital Signs
Description	Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

Arm/Group Title	TAK-831 500 mg	[14C]TAK-831 50 μg	[14C]TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6	6	6
Count of Participants [Participants]	0 0%	0 NaN	0 NaN

33. Secondary Outcome

Title	Number of Participants With TEAEs Related to Laboratory Parameters
Description	The laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

Arm/Group Title	TAK-831 500 mg	[14C]TAK-831 50 μg	[14C]TAK-831 500 mg
Arm/Group Description	TAK-831 500 mg, tablet, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Measure Participants	6	6	6
Count of Participants [Participants]	0 0%	0 NaN	0 NaN

Adverse Events

Time Frame	From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days)
Adverse Event Reporting Description	Data is reported as per the treatment received in Periods 1 and 2.
Arm/Group Title	TAK-831 500 mg		[14C]TAK-831 50 μg		[14C]TAK-831 500 mg
Arm/Group Description	TAK-831 5 X 100 mg tablets, orally, once on Day 1 of Treatment Period 1.		[14C]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.		[14C]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
All Cause Mortality
	TAK-831 500 mg		[14C]TAK-831 50 μg		[14C]TAK-831 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	TAK-831 500 mg		[14C]TAK-831 50 μg		[14C]TAK-831 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	TAK-831 500 mg		[14C]TAK-831 50 μg		[14C]TAK-831 500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		2/6 (33.3%)
Eye disorders
Eye irritation	0/6 (0%)		0/6 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Abdominal discomfort	0/6 (0%)		0/6 (0%)		1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/6 (0%)		0/6 (0%)		1/6 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Generally, the PI may publish results of the study following the publication of results by the Sponsor.