TAK-071 Scopolamine-Induced Cognitive Impairment Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-21

Study Completion Date

2017-08-08

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

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.

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

Scopolamine subcutaneous injection

TAK-071

Intervention Type DRUG

TAK-071 DIC

Donepezil

Intervention Type DRUG

Donepezil over-encapsulated tablet

Scopolamine Placebo

Intervention Type DRUG

Scopolamine placebo-matching subcutaneous injection

TAK-071 Placebo

Intervention Type DRUG

TAK-071 placebo-matching DIC

Donepezil Placebo

Intervention Type DRUG

Donepezil placebo-matching over-encapsulated tablet

Interventions

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Scopolamine

Scopolamine subcutaneous injection

Intervention Type DRUG

TAK-071

TAK-071 DIC

Intervention Type DRUG

Donepezil

Donepezil over-encapsulated tablet

Intervention Type DRUG

Scopolamine Placebo

Scopolamine placebo-matching subcutaneous injection

Intervention Type DRUG

TAK-071 Placebo

TAK-071 placebo-matching DIC

Intervention Type DRUG

Donepezil Placebo

Donepezil placebo-matching over-encapsulated tablet

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes