Status:
COMPLETED
A Study to Explore the Routes of Elimination of MDV3100
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Healthy Subjects
Pharmacokinetics of MDV3100
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A study to investigate the excretion routes of radio-labelled MDV3100.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01911715
Start Date
April 1 2011
End Date
July 1 2011
Last Update
July 30 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PRA International
Zuidlaren, Netherlands, 9471GP