At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
TAK-385 +2 moredrug
Likely dose
Not stated in 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.
A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Fluconazole and Atorvastatin on the Pharmacokinetics of a Single Oral Dose of TAK-385 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-385, Fluconazole, and 1 other intervention for Prostate Cancer and Endometriosis. Completed, enrolled 40 participants.
Detailed Summary
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Endometriosis
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedMar 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedMar 21, 2014
Enrollment StartMar 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.3 years ago
Interventions
TAK-385drug
TAK-385 tablets
Fluconazoledrug
Fluconazole tablets
Atorvastatindrug
Atorvastatin tablets