TAK-071 Scopolamine-Induced Cognitive Impairment Study

Sponsor
Takeda (Industry)
Overall Status
Terminated
CT.gov ID
NCT02918266
Collaborator
(none)
18
1
11
8.5
2.1

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
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

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controlled, 5-Period Crossover, Phase 1b Study To Evaluate The Effects Of Single Oral Administration of TAK-071 On Scopolamine-Induced Cognitive Impairment In Healthy Subjects
Study Start Date :
Nov 21, 2016
Actual Primary Completion Date :
Aug 2, 2017
Actual Study Completion Date :
Aug 8, 2017

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  1. 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)]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. 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]

  8. 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]

  9. 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]

  10. 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]

  11. 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]

  12. 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]

  13. 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]

  14. 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]

  15. 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

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 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:
  1. Able to perform the CogState battery.

  2. Change from Baseline (average) in total GMLT errors of less than or equal to (<=) -5 at 2 hours postdose of scopolamine.

  3. Sleepiness score less than (<) 8 on the karolinska sleepiness scale (KSS) at 2 hours postdose of scopolamine.

  4. 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:
  1. 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.

  2. 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.

  3. Has poor peripheral venous access.

  4. 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.

  5. 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.

  6. 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.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02918266
Other Study ID Numbers:
  • TAK-071-1002
  • U1111-1184-2278
First Posted:
Sep 28, 2016
Last Update Posted:
Jun 14, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Takeda
Additional relevant MeSH terms:

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.
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
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

1. Primary Outcome
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
2. Secondary Outcome
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
3. Secondary Outcome
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
4. Secondary Outcome
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
5. Secondary Outcome
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
6. Secondary Outcome
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%
7. Secondary Outcome
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%
8. Secondary Outcome
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%
9. Secondary Outcome
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%
10. Secondary Outcome
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)
11. Secondary Outcome
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
12. Secondary Outcome
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)
13. Secondary Outcome
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)
14. Secondary Outcome
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
15. Secondary Outcome
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)
16. Secondary Outcome
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

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

Name/Title Medical Director
Organization Takeda
Phone +1-877-825-3327
Email trialdisclosures@takeda.com
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02918266
Other Study ID Numbers:
  • TAK-071-1002
  • U1111-1184-2278
First Posted:
Sep 28, 2016
Last Update Posted:
Jun 14, 2019
Last Verified:
Mar 1, 2019