NCT01913379

Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

Conditions

• Healthy Subjects
• Pharmacokinetics
• Drug-Drug Interaction

Interventions

Type	Name	Description
DRUG	MDV3100	Oral
DRUG	Gemfibrozil	Oral
DRUG	Itraconazole	Oral

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2013-08-01
• Last updated: 2013-08-01

Locations

1 site across 1 country: France