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Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects

NCT03687684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-831

TAK-831 Tablets.

DRUG

Placebo

TAK-831 Matching Placebo Tablets.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2019-06-09
Completion
2019-06-19

Countries

  • Japan

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Entities

Drugs
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 NCT03687684 on ClinicalTrials.gov