TAK-071 Scopolamine-Induced Cognitive Impairment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02918266

Recruitment Status : Terminated (Terminated prematurely due to indication change.)

First Posted : September 28, 2016

Results First Posted : June 14, 2019

Last Update Posted : June 14, 2019

Sponsor:

Information provided by (Responsible Party):

Takeda

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
Healthy Volunteers	Drug: Scopolamine Drug: TAK-071 Drug: Donepezil Drug: Scopolamine Placebo Drug: TAK-071 Placebo Drug: Donepezil Placebo	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

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Study Type :	Interventional (Clinical Trial)
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 :	November 21, 2016
Actual Primary Completion Date :	August 2, 2017
Actual Study Completion Date :	August 8, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Scopolamine Scopolamine hydrobromide Butylscopolamine bromide

U.S. FDA Resources

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 :

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 [ Time Frame: Baseline, 2 hours post scopolamine dose on Day 2 ]

Secondary Outcome Measures :

Part 2: Change From Baseline in Total Number of Errors on the GMLT [ Time Frame: Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours) ]
Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071 [ Time Frame: Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose ]
Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071 [ Time Frame: Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose ]
Part 2: TEmax: Time to Reach GMLT Emax for TAK-071 [ Time Frame: Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose ]
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 ]
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose [ Time Frame: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 ]
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose [ Time Frame: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 ]
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose [ Time Frame: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1 ]
Cmax: Maximum Observed Plasma Concentration for TAK-071 [ 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 ]
Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071 [ 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 ]
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071 [ 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 ]
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071 [ 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 ]
AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071 [ 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 ]
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 [ 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 ]
T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071 [ 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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:

Able to perform the CogState battery.
Change from Baseline (average) in total GMLT errors of less than or equal to (<=) -5 at 2 hours postdose of scopolamine.
Sleepiness score less than (<) 8 on the karolinska sleepiness scale (KSS) at 2 hours postdose of scopolamine.
Passes a hearing test with at least 80 percent (%) correct responses and no more than 20% false positives. This test can be repeated once to determine eligibility.

Exclusion Criteria:

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 4 or more units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1 of Period 1. Cotinine test is positive at Screening or Check-in (Day -1) of Period 1.
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.
Is a shift worker (night, late, or early resulting in irregular bed times) or has crossed or will cross more than 2 time zones within 48 hours in the period from 48 hours prior to Treatment Period 1, Day 1 until the end of Treatment Period 5.
Reports symptoms suggesting evidence of a current sleep disorder or history of sleep disorder, including but not limited to sleep apnea, heavy snoring, primary or chronic insomnia, narcolepsy or restless leg syndrome, as judged by medical history.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918266

Locations

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United States, California

Glendale, California, United States

Sponsors and Collaborators

Takeda

Study Documents (Full-Text)

Documents provided by Takeda:

Study Protocol [PDF] March 10, 2017

Statistical Analysis Plan [PDF] March 22, 2018

More Information

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Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT02918266
Other Study ID Numbers:	TAK-071-1002 U1111-1184-2278 ( Registry Identifier: WHO )
First Posted:	September 28, 2016 Key Record Dates
Results First Posted:	June 14, 2019
Last Update Posted:	June 14, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Keywords provided by Takeda:


Drug Therapy

Additional relevant MeSH terms:

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Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders Scopolamine Donepezil Butylscopolammonium Bromide Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents	Physiological Effects of Drugs Nootropic Agents Adjuvants, Anesthesia Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Mydriatics Cholinergic Antagonists Muscarinic Antagonists Parasympatholytics

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