Status:
COMPLETED
Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Healthy Subjects
Pharmacokinetics
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.
Eligibility Criteria
Inclusion
- Body weight of at least 65.0 kg and no greater than 85.0 kg.
- Body Mass Index (BMI) of at least 18.5 and no greater than 30.0 kg/m2.
Exclusion
- Known or suspected hypersensitivity to MDV3100, itraconazole, gemfibrozil, any components of the formulations used, or any history of liver toxicity with other drugs.
- Confirmed CYP2C8 PM status based on genotyping analysis.
- Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
- History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
- Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic BP \>140 mmHg ; mean diastolic BP \>90 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
- A QTc interval of \>430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01913379
Start Date
August 1 2011
End Date
December 1 2011
Last Update
August 1 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SGS
Paris, France, 75015