Trials / Completed
CompletedNCT01911728
Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates
A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Astellas Pharma Europe B.V. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MDV3100 | Oral |
| DRUG | Pioglitazone | Oral |
| DRUG | Warfarin | Oral |
| DRUG | Omeprazole | Oral |
| DRUG | Midazolam | Oral |
Timeline
- Start date
- 2011-07-25
- Primary completion
- 2012-02-21
- Completion
- 2012-02-21
- First posted
- 2013-07-30
- Last updated
- 2017-06-26
Locations
2 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT01911728. Inclusion in this directory is not an endorsement.