NCT02093390

A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385. The study enrolled 40 patients. Participants were assigned to one of the two treatment groups: * TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14 * TAK-385 40 mg and atorvastatin 80 mg on Days 6-14 Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14. This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.

Conditions

• Prostate Cancer
• Endometriosis

Interventions

Type	Name	Description
DRUG	TAK-385	TAK-385 tablets
DRUG	Fluconazole	Fluconazole tablets
DRUG	Atorvastatin	Atorvastatin tablets

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-03-21
• Last updated: 2016-06-06
• Results posted: 2016-06-06