CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
TAK-385 40 mgdrug
Likely dose
TAK-385 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02792062
NCT02792062Phase 1Completed
CompareCT.gov

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

Takeda·interventional·Posted Jun 7, 2016·Updated Dec 18, 2017

In Brief

A Phase 1 clinical trial evaluating TAK-385 40 mg for Japanese Premenopausal Healthy Adult Women. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Premenopausal Healthy Adult Women
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 7, 2016
Enrollment StartJul 4, 2016
Primary CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago

Interventions

TAK-385 40 mgdrug

TAK-385 40 mg tablet