Status:
COMPLETED
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Healthy Subjects
Castration Resistant Prostate Cancer (CRPC)
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolera...
Eligibility Criteria
Inclusion
- The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening).
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration.
Exclusion
- Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
- Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in.
- Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject.
- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01911741
Start Date
November 1 2012
End Date
March 1 2013
Last Update
July 30 2013
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany, 14050