A Study to Explore the Routes of Elimination of MDV3100

Phase 1CompletedNCT01911715

Astellas Pharma Europe B.V.6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects Pharmacokinetics of MDV3100

Interventions

MDV3100DRUG

Oral

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PRA International

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Maximum concentration (Cmax)