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Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants

NCT02769065 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2019-06-10

Study results available
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Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).

Conditions

  • Alzheimer Disease
  • Healthy Volunteers

Interventions

DRUG

TAK-071

TAK-071 capsules

DRUG

Donepezil

Donepezil over-encapsulated tablet

DRUG

TAK-071 Placebo

TAK-071 placebo-matching capsules

DRUG

Donepezil Placebo

Donepezil placebo-matching over-encapsulated tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-05
Primary Completion
2017-06-08
Completion
2017-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769065 on ClinicalTrials.gov