TAK-071 Scopolamine-Induced Cognitive Impairment Study
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning Test (GMLT) (total number of errors).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
The drug being tested in this study is called TAK-071. This study will look at the effect of a single oral dose of TAK-071, a novel muscarinic acetylcholine receptor 1 positive allosteric modulator, on scopolamine-induced deficits in cognitive function in healthy adult male participants. The study consists of two parts: Part 1 is a substudy to explore PK profile of TAK-071 in the presence of light meal and coadministration of scopolamine to determine TAK-071 dose for the next part; Part 2 is the main the study to assess the effects of TAK-071 on scopolamine-induced cognitive impairment. The study will enroll approximately 6 participants in Part 1 and 40 participants in Part 2. Participant will be assigned to received TAK-071 along with scopolamine in Part 1 and will be randomly assigned to one of the ten treatment sequences in Part 2-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
Part 2: Treatment Sequence ABDEC Part 2: Treatment Sequence BCEAD Part 2: Treatment Sequence CDABE Part 2: Treatment Sequence DEBCA Part 2: Treatment Sequence EACDB Part 2: Treatment
Sequence ACBED Part 2: Treatment Sequence BDCAE Part 2: Treatment Sequence CEDBA Part 2:
Treatment Sequence DAECB Part 2: Treatment Sequence EBADC Where A=scopolamine matching placebo SC + TAK-071 matching placebo oral (PO) + donepezil matching placebo PO; B=scopolamine 0.5 mg SC + TAK-071 matching placebo PO + donepezil matching placebo PO; C=scopolamine 0.5 mg SC + TAK-071 PO + donepezil matching placebo PO; D=scopolamine 0.5 mg SC
- TAK-071 PO + donepezil 10 mg PO; and E=scopolamine 0.5 mg SC + TAK-071 matching placebo PO
- donepezil 10 mg PO.
The dose of TAK-071 that was well-tolerated in the TAK-071-1001 study (NCT02769065) will be selected, based on the safety and tolerability data from the single-rising dose (SRD) study for administration in Part 1. Each participant will also receive scopolamine 0.5 mg, injection, SC, once at the time of Screening. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 5.7 weeks in Part 1 and 21 weeks in Part 2. Participants will remain confined to the clinic for 4 days during Part 1 and 3 days during the each intervention period in Part 2. Participants will be contacted by telephone on Day 12 in Part 1 and Day 9 of Period 5 in Part 2 for a follow-up assessment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Part 1: TAK-071 80 mg + Scopolamine 0.5 mg TAK-071 80 milligram (mg), drug in capsule (DIC), orally, Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, Day 2. TAK-071 will be taken 24 hours before scopolamine injection. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
|
Experimental: Part 2: Treatment Sequence ABDEC TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period1(A); followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(C). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence BCEAD TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period4(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(D). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence CDABE TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(C);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period3(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(E). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence DEBCA TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period5(A). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence EACDB TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period2(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(C);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(B). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence ACBED TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period1(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(D). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence BDCAE TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(D);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period4(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(E). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence CEDBA TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period5(A). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence DAECB TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period2(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(C); followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(B). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Experimental: Part 2: Treatment Sequence EBADC TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period3(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(D);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(C). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period. |
Drug: Scopolamine
Scopolamine subcutaneous injection
Drug: TAK-071
TAK-071 DIC
Drug: Donepezil
Donepezil over-encapsulated tablet
Drug: Scopolamine Placebo
Scopolamine placebo-matching subcutaneous injection
Drug: TAK-071 Placebo
TAK-071 placebo-matching DIC
Drug: Donepezil Placebo
Donepezil placebo-matching over-encapsulated tablet
|
Outcome Measures
Primary Outcome Measures
- Part 2: Change From Baseline in Total Number of Errors on the Groton Maze Learning Test (GMLT) at 2 Hours Post-Scopolamine Dose on Day 2 [Baseline, 2 hours post scopolamine dose on Day 2]
Secondary Outcome Measures
- Part 2: Change From Baseline in Total Number of Errors on the GMLT [Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours)]
- Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071 [Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071 [Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- Part 2: TEmax: Time to Reach GMLT Emax for TAK-071 [Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose]
- Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1]
- Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose [Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1]
- Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose [Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1]
- Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose [Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1]
- Cmax: Maximum Observed Plasma Concentration for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose]
- AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
- T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071 [Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Additional inclusion criteria for Part 2:
-
Able to perform the CogState battery.
-
Change from Baseline (average) in total GMLT errors of less than or equal to (<=) -5 at 2 hours postdose of scopolamine.
-
Sleepiness score less than (<) 8 on the karolinska sleepiness scale (KSS) at 2 hours postdose of scopolamine.
-
Passes a hearing test with at least 80 percent (%) correct responses and no more than 20% false positives. This test can be repeated once to determine eligibility.
Exclusion Criteria:
-
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 4 or more units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
-
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1 of Period 1. Cotinine test is positive at Screening or Check-in (Day -1) of Period 1.
-
Has poor peripheral venous access.
-
Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.
-
Is a shift worker (night, late, or early resulting in irregular bed times) or has crossed or will cross more than 2 time zones within 48 hours in the period from 48 hours prior to Treatment Period 1, Day 1 until the end of Treatment Period 5.
-
Reports symptoms suggesting evidence of a current sleep disorder or history of sleep disorder, including but not limited to sleep apnea, heavy snoring, primary or chronic insomnia, narcolepsy or restless leg syndrome, as judged by medical history.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Glendale | California | United States |
Sponsors and Collaborators
- Takeda
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- TAK-071-1002
- U1111-1184-2278
Study Results
Participant Flow
Recruitment Details | Participants took part in the study at 1 investigative site in the United states from 21 November 2016 to 08 August 2017. |
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Pre-assignment Detail | Healthy male participants were enrolled in this 2-part study to receive: TAK-071, scopolamine in Part 1; TAK-071, scopolamine and donepezil in a cross-over sequence in Part 2. The study was terminated prior to start of Part 2 intervention period 2 due to indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment Sequence ABDEC | Part 2: Treatment Sequence BCEAD | Part 2: Treatment Sequence CDABE | Part 2: Treatment Sequence DEBCA | Part 2: Treatment Sequence EACDB | Part 2: Treatment Sequence ACBED | Part 2: Treatment Sequence BDCAE | Part 2: Treatment Sequence CEDBA | Part 2: Treatment Sequence DAECB | Part 2: Treatment Sequence EBADC |
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Arm/Group Description | TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period. |
Period Title: Part 1 | |||||||||||
STARTED | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 1 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 1 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Part 1 | |||||||||||
STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment Sequence ABDEC | Part 2: Treatment Sequence BCEAD | Part 2: Treatment Sequence CDABE | Part 2: Treatment Sequence DEBCA | Part 2: Treatment Sequence EACDB | Part 2: Treatment Sequence ACBED | Part 2: Treatment Sequence BDCAE | Part 2: Treatment Sequence CEDBA | Part 2: Treatment Sequence DAECB | Part 2: Treatment Sequence EBADC | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period. | TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period. | Total of all reporting groups |
Overall Participants | 6 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 18 |
Age (Count of Participants) | ||||||||||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
6
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
2
100%
|
1
100%
|
2
100%
|
1
100%
|
1
100%
|
18
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
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%
|
0
0%
|
Male |
6
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
2
100%
|
1
100%
|
2
100%
|
1
100%
|
1
100%
|
18
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||||
Hispanic or Latino |
3
50%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
1
100%
|
0
0%
|
1
100%
|
1
50%
|
0
0%
|
1
100%
|
8
44.4%
|
Not Hispanic or Latino |
3
50%
|
1
100%
|
1
100%
|
0
0%
|
1
100%
|
0
0%
|
2
100%
|
0
0%
|
1
50%
|
1
100%
|
0
0%
|
10
55.6%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||||||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
5.6%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
16.7%
|
1
100%
|
1
100%
|
0
0%
|
1
100%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
27.8%
|
White |
3
50%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
1
100%
|
0
0%
|
1
100%
|
2
100%
|
1
100%
|
1
100%
|
10
55.6%
|
More than one race |
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
11.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||||||||||
United States |
6
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
2
100%
|
1
100%
|
2
100%
|
1
100%
|
1
100%
|
18
100%
|
Smoking Classification (Count of Participants) | ||||||||||||
Never smoked |
6
100%
|
1
100%
|
1
100%
|
0
0%
|
1
100%
|
1
100%
|
2
100%
|
1
100%
|
2
100%
|
1
100%
|
0
0%
|
16
88.9%
|
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%
|
Ex-smoker |
0
0%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
2
11.1%
|
Alcohol Classification (Count of Participants) | ||||||||||||
Never drunk |
3
50%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
1
100%
|
2
100%
|
0
0%
|
1
50%
|
1
100%
|
0
0%
|
10
55.6%
|
Current drinker: had less than (<) 4 units per day |
3
50%
|
0
0%
|
0
0%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
1
100%
|
7
38.9%
|
Current drinker: had 4 or more units per day |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Ex-drinker |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
1
5.6%
|
Caffeine Consumption (Count of Participants) | ||||||||||||
Had caffeine consumption |
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
50%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
5
27.8%
|
Had no caffeine consumption |
4
66.7%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
0
0%
|
1
50%
|
1
100%
|
1
50%
|
1
100%
|
1
100%
|
13
72.2%
|
Academic Qualifications (Count of Participants) | ||||||||||||
No degree or diploma |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Elementary school |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
High school |
3
50%
|
1
100%
|
0
0%
|
1
100%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
6
33.3%
|
Non university degree |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
1
5.6%
|
University |
3
50%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
1
100%
|
2
100%
|
1
100%
|
1
50%
|
1
100%
|
1
100%
|
11
61.1%
|
Outcome Measures
Title | Part 2: Change From Baseline in Total Number of Errors on the Groton Maze Learning Test (GMLT) at 2 Hours Post-Scopolamine Dose on Day 2 |
---|---|
Description | |
Time Frame | Baseline, 2 hours post scopolamine dose on Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|
Arm/Group Description | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Part 2: Change From Baseline in Total Number of Errors on the GMLT |
---|---|
Description | |
Time Frame | Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours) |
Outcome Measure Data
Analysis Population Description |
---|
No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|
Arm/Group Description | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071 |
---|---|
Description | |
Time Frame | Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|
Arm/Group Description | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071 |
---|---|
Description | |
Time Frame | Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|
Arm/Group Description | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Part 2: TEmax: Time to Reach GMLT Emax for TAK-071 |
---|---|
Description | |
Time Frame | Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|
Arm/Group Description | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) |
---|---|
Description | |
Time Frame | Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set included all participants who were enrolled and received 1 dose of study drug. |
Arm/Group Title | Scopolamine 0.5 mg SC + TAK-071 80 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 3 | 2 | 3 | 2 | 2 |
Number [percentage of participants] |
66.7
1111.7%
|
66.7
6670%
|
100.0
10000%
|
100.0
10000%
|
100.0
10000%
|
100.0
10000%
|
Title | Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose |
---|---|
Description | |
Time Frame | Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set included all participants who were enrolled and received 1 dose of study drug. |
Arm/Group Title | Scopolamine 0.5 mg SC + TAK-071 80 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 3 | 2 | 3 | 2 | 2 |
Number [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose |
---|---|
Description | |
Time Frame | Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set included all participants who were enrolled and received 1 dose of study drug. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 3 | 2 | 3 | 2 | 2 |
Diastolic Blood Pressure (mmHg)/Supine <50 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Pulse rate/supine: <50 beats per minute |
33.3
555%
|
33.3
3330%
|
50.0
5000%
|
0
0%
|
0
0%
|
50.0
5000%
|
Temperature: <35.6 Celsius |
0
0%
|
0
0%
|
0
0%
|
33.3
3330%
|
0
0%
|
0
0%
|
Temperature: >37.7 Celsius |
16.7
278.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose |
---|---|
Description | |
Time Frame | Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set included all participants who were enrolled and received 1 dose of study drug. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 3 | 2 | 3 | 2 | 2 |
Number [percentage of participants] |
16.7
278.3%
|
0
0%
|
50.0
5000%
|
0
0%
|
0
0%
|
50.0
5000%
|
Title | Cmax: Maximum Observed Plasma Concentration for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)] |
1066
(16.8)
|
Title | Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Median (Full Range) [hours] |
30.00
|
Title | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Geometric Mean (Geometric Coefficient of Variation) [hour*nanogram per milliliter (h*ng/mL)] |
82010
(25.0)
|
Title | AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
19330
(16.0)
|
Title | AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
As per change in planned analyses, data was not collected. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 |
Title | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
94100
(26.8)
|
Title | T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071 |
---|---|
Description | |
Time Frame | Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose |
Outcome Measure Data
Analysis Population Description |
---|
The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change. |
Arm/Group Title | Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E |
---|---|---|---|---|---|---|
Arm/Group Description | TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. |
Measure Participants | 6 | 0 | 0 | 0 | 0 | 0 |
Mean (Standard Deviation) [hours] |
47.02
(14.864)
|
Adverse Events
Time Frame | Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug up to Day 12 in Part 1 and Day 9 of Period 1 in Part 2 (study termination) 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: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E | ||||||
Arm/Group Description | TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. | ||||||
All Cause Mortality |
||||||||||||
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E | |||||||
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 | 0/6 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/2 (0%) | 0/2 (0%) | ||||||
Serious Adverse Events |
||||||||||||
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E | |||||||
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 | 0/6 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 0/2 (0%) | 0/2 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg | Part 2: Treatment A | Part 2: Treatment B | Part 2: Treatment C | Part 2: Treatment D | Part 2: Treatment E | |||||||
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 | 4/6 (66.7%) | 2/3 (66.7%) | 2/2 (100%) | 3/3 (100%) | 2/2 (100%) | 2/2 (100%) | ||||||
Gastrointestinal disorders | ||||||||||||
Abdominal pain upper | 1/6 (16.7%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/2 (0%) | 0/2 (0%) | ||||||
Nausea | 1/6 (16.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 1/2 (50%) | 1/2 (50%) | ||||||
Diarrhoea | 0/6 (0%) | 0/3 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/2 (0%) | 0/2 (0%) | ||||||
Odynophagia | 0/6 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 0/2 (0%) | 0/2 (0%) | ||||||
Vomiting | 0/6 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 1/2 (50%) | 0/2 (0%) | ||||||
General disorders | ||||||||||||
Asthenia | 0/6 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | 1/2 (50%) | 0/2 (0%) | ||||||
Nervous system disorders | ||||||||||||
Somnolence | 4/6 (66.7%) | 2/3 (66.7%) | 1/2 (50%) | 2/3 (66.7%) | 0/2 (0%) | 0/2 (0%) | ||||||
Dizziness | 1/6 (16.7%) | 1/3 (33.3%) | 0/2 (0%) | 0/3 (0%) | 0/2 (0%) | 1/2 (50%) | ||||||
Headache | 1/6 (16.7%) | 0/3 (0%) | 1/2 (50%) | 1/3 (33.3%) | 0/2 (0%) | 1/2 (50%) | ||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||
Cough | 0/6 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | 0/2 (0%) | 0/2 (0%) |
Limitations/Caveats
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 |
trialdisclosures@takeda.com |
- TAK-071-1002
- U1111-1184-2278