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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01911741
Other study ID # 9785-CL-0010
Secondary ID 2012-002502-49
Status Completed
Phase Phase 1
First received July 26, 2013
Last updated July 26, 2013
Start date November 2012
Est. completion date March 2013

Study information

Verified date July 2013
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
MDV3100
Oral

Locations

Country Name City State
Germany Parexel International GmbH Berlin

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Europe B.V. Medivation, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions AUC0-72h (AUC from time zero to 72h post dose), AUC0-t, AUC0-inf, %AUC (Percentage of AUC), Cmax, tmax (Time to attain Cmax), ?z (Terminal elimination rate constant), t1/2 (Terminal elimination half life), (MPR) metabolites to parent ratio, MPR(molecular weight corrected [MWC]), %AUC, CL/F (apparent oral clearance), Vz/F (apparent volume of distribution) Day 1 through Day 50 (26 times) No
Secondary Safety and tolerability of oral formulations of enzalutamide adverse events, physical examination, vital signs, clinical laboratory tests, 12-lead Electrocardiogram (ECG) Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal) Yes
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