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drugset / Trial / NCT02769065

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 ↗

Phase 1 Terminated 179 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2016-05-05
Primary completion
2017-06-08
Completion
2017-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 5 mg Oral
Subject Donepezil Small molecule 10 mg Oral
Subject TAK-071 Small molecule 1 mg Oral
Subject TAK-071 Small molecule 3 mg Oral
Subject TAK-071 Small molecule 9 mg Oral
Subject TAK-071 Small molecule 10 mg Oral
Subject TAK-071 Small molecule 15 mg Oral
Subject TAK-071 Small molecule 20 mg Oral
Subject TAK-071 Small molecule 40 mg Oral
Subject TAK-071 Small molecule 60 mg Oral
Subject TAK-071 Small molecule 80 mg Oral
Subject TAK-071 Small molecule 120 mg Oral
Subject TAK-071 Small molecule 160 mg Oral

Indications

Alzheimer disease