A Study to Explore the Routes of Elimination of MDV3100

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Pharmacokinetics of MDV3100

Treatments

Drug: MDV3100

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911715

9785-CL-0001

2011-000089-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.