A Study to Explore the Routes of Elimination of MDV3100

NCT ID: NCT01911715

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-07-31

Brief Summary

A study to investigate the excretion routes of radio-labelled MDV3100.

Conditions

Healthy Subjects; Pharmacokinetics of MDV3100

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Oral MDV3100 dose

Group Type: EXPERIMENTAL

MDV3100

Intervention Type: DRUG

Oral

Interventions

MDV3100

Oral

Intervention Type: DRUG

Other Intervention Names

Xtandi; enzalutamide

Eligibility Criteria

Inclusion Criteria

• Body Mass Index within 18.5 to 30.0kg/m2
• Regular defecation pattern (minimum once per 2 days).
• Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies as defined in the protocol.

Exclusion Criteria

• Known or suspected hypersensitivity to MDV3100, or any components of the formulation used.
• Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
• Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg ; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
• A QTc interval of > 430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
• Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).
• Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
• Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medivation, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Operation Senior Research Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

PRA International

Zuidlaren, , Netherlands

Countries

Netherlands

References

Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

Reference Type: DERIVED

PMID: 25917876 (View on PubMed)

Other Identifiers

2011-000089-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

9785-CL-0001

Identifier Type: -

Identifier Source: org_study_id