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

NCT01911741 | Completed Phase 1

• 2 other identifiers: 9785-CL-00102012-002502-49
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Castration Resistant Prostate Cancer (CRPC); Relative Bioavailability; MDV3100

Keywords

Phase I; Enzalutamide; Relative bioavailability of MDV3100; Immediate release oral formulation; Xtandi

Outcome Measures

Primary Outcomes (1)

• Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions

  AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)

  Day 1 through Day 50 (26 times)

Secondary Outcomes (2)

• Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions

  Day 1 through Day 50 (26 times)

• Safety and tolerability of oral formulations of enzalutamide

  Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal)

Study Arms (3)

Treatment A

EXPERIMENTAL

Single dose of 4 liquid-filled capsules of MDV3100 reference formulation

Drug: MDV3100

Treatment B

EXPERIMENTAL

Single dose of 2 tablets of MDV3100 formulation tablet B

Drug: MDV3100

Treatment C

EXPERIMENTAL

Single dose of 2 tablets of MDV3100 formulation tablet C

Drug: MDV3100

Interventions

MDV3100 DRUG

Oral

Also known as: enzalutamide, Xtandi

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead
• Medivation, Inc.: collaborator

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

enzalutamide

Study Officials

• Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

DE (1)