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A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation

NCT03101293 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-831

TAK-831 film-coated tablet.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2017-05-19
Completion
2017-05-26
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 NCT03101293 on ClinicalTrials.gov