Trial record 3 of 75 for:    Enzalutamide

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

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01911741
First received: July 26, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Castration Resistant Prostate Cancer (CRPC)
Relative Bioavailability
MDV3100
Drug: MDV3100
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions [ Time Frame: Day 1 through Day 50 (26 times) ] [ Designated as safety issue: No ]
    AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration)


Secondary Outcome Measures:
  • Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions [ Time Frame: Day 1 through Day 50 (26 times) ] [ Designated as safety issue: No ]
    AUC0-72h (AUC from time zero to 72h post dose), AUC0-t, AUC0-inf, %AUC (Percentage of AUC), Cmax, tmax (Time to attain Cmax), λz (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)

  • Safety and tolerability of oral formulations of enzalutamide [ Time Frame: Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal) ] [ Designated as safety issue: Yes ]
    adverse events, physical examination, vital signs, clinical laboratory tests, 12-lead Electrocardiogram (ECG)


Enrollment: 55
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Single dose of 4 liquid-filled capsules of MDV3100 reference formulation
Drug: MDV3100
Oral
Other Names:
  • enzalutamide
  • Xtandi
Experimental: Treatment B
Single dose of 2 tablets of MDV3100 formulation tablet B
Drug: MDV3100
Oral
Other Names:
  • enzalutamide
  • Xtandi
Experimental: Treatment C
Single dose of 2 tablets of MDV3100 formulation tablet C
Drug: MDV3100
Oral
Other Names:
  • enzalutamide
  • Xtandi

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911741

Locations
Germany
Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Medivation, Inc.
Investigators
Study Chair: Study Manager Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01911741     History of Changes
Other Study ID Numbers: 9785-CL-0010, 2012-002502-49
Study First Received: July 26, 2013
Last Updated: July 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:
Phase I
Enzalutamide
Relative bioavailability of MDV3100
Immediate release oral formulation
Xtandi

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014