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Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants

NCT02396147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-07-25

Study results available
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Summary

The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-385 T2 Formulation

TAK-385 T2 Formulation tablets

DRUG

TAK-385 T4 Formulation B

TAK-385 T4 Formulation B tablets

DRUG

TAK-385 T4 Formulation C

TAK-385 T4 Formulation C tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-04-30
Completion
2015-06-30

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 NCT02396147 on ClinicalTrials.gov