NCT02792062

A Food Effect Study of TAK-385 Final Formulation

A Phase 1, Randomized, Open-label, Crossover Study to Assess Food Effect on Single Oral Dose Administration of TAK-385 Final Formulation in Premenopausal Healthy Adult Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.

Detailed description

This is a phase 1 clinical pharmacological study of TAK-385 in Japanese premenopausal healthy adult women. Using an open-label crossover design, food effects on the pharmacokinetics and safety of TAK-385 will be evaluated in participants receiving a single oral dose of TAK-385 40 mg in fasted condition without breakfast, before breakfast, or after breakfast. Participants determined to be eligible will be randomly assigned to one of Groups A to F prior to study medication administration in Period 1; subsequently, participants will receive one TAK-385 40 mg tablet in fasted condition without breakfast (following a minimum 10-hour overnight fast), before breakfast (30 minutes before starting breakfast), or after breakfast (30 minutes after starting breakfast) in Periods 1, 2, and 3.

Conditions

• Japanese Premenopausal Healthy Adult Women

Interventions

Type	Name	Description
DRUG	TAK-385 40 mg	TAK-385 40 mg tablet

Timeline

• Start date: 2016-07-04
• Primary completion: 2016-08-31
• Completion: 2016-08-31
• First posted: 2016-06-07
• Last updated: 2017-12-18
• Results posted: 2017-11-17

Locations

1 site across 1 country: Japan