Overview

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

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
Male
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 tolerability of oral formulations. Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborator:
Medivation, Inc.
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.