TAK-071 Scopolamine-Induced Cognitive Impairment Study
Condition: Healthy Volunteers
MeSH terms: Cognitive Dysfunction
Intervention: Scopolamine; TAK-071; Donepezil; Scopolamine Placebo; TAK-071 Placebo; Donepezil Placebo
Intervention description: Scopolamine subcutaneous injection; TAK-071 DIC; Donepezil over-encapsulated tablet; Scopolamine placebo-matching subcutaneous injection; TAK-071 placebo-matching DIC; Donepezil placebo-matching over-encapsulated tablet
Intervention MeSH terms: Scopolamine; Donepezil; Butylscopolammonium Bromide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

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).
    

Eligibility 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:

          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.