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A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants

NCT03224325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

TAK-831 Tablet T2

Tak-831 tablets.

DRUG

Placebo

TAK-831 placebo-matching suspension.

DRUG

TAK-831 Suspension

TAK-831 Suspension.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2018-09-09
Completion
2018-09-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03224325 on ClinicalTrials.gov