A Phase I open-label study to investigate the mass balance and biotransformation of a single oral 160 mg (100 µCi) dose of 14C-MDV3100 (ASP9785) in healthy male subjects

Completed

• Conditions: prostate cancer; prostate carcinoom; 10038597

• Registration Number: NL-OMON35823
• Lead Sponsor: Astellas Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

-Healthy male subjects
-18 to 55 years inclusive.
-BMI 18.5 to 30.0 kg/m2
-Non-smoker, or not more than 10 cigarettes for at least three months before drug administration

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 12 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- radiokinetics<br /><br>- pharmacokinetics<br /><br>- safety<br /><br>- tolerability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>