Clinical trial NCT01911741: 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
Official title: A Phase I, Single-center, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and Tablet Formulations of Enzalutamide Following a Single 160 mg Dose Under Fasted Conditions in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Castration Resistant Prostate Cancer (CRPC)
Relative Bioavailability
MDV3100
Keywords: Phase I
Enzalutamide
Relative bioavailability of MDV3100
Immediate release oral formulation
Xtandi
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2013-07-30
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility 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.

Primary outcomes:
measure: Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
timeFrame: Day 1 through Day 50 (26 times)
Secondary outcomes:
measure: Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions
timeFrame: Day 1 through Day 50 (26 times)
measure: Safety and tolerability of oral formulations of enzalutamide
timeFrame: Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Study Manager
role: STUDY_CHAIR
References: