14C-ARN-509 Microdose Absolute Bioavailability and Microtracer Absorption, Metabolism, and Excretion study in healthy volunteers

Completed

• Conditions: Tumoren van de prostaat; Cancer of the prostate; Prostate Cancer

• Registration Number: NL-OMON38777
• Lead Sponsor: Aragon Pharmaceuticals Inc

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: 12

Inclusion Criteria

Healthy male volunteers
50-80 years, inclusive
BMI: 18.5 - 30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study.
In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: blood and plasma concentrations of radioactivity, plasma<br /><br>concentrations of ARN-509<br /><br>metabolite patterns in plasma, excretion of radioactivity, metabolite patterns<br /><br>in urine, feces and expired air, metabolite identity,<br /><br>absorption of ARN-509<br /><br>Safety: adverse events, vital signs, ECG, clinical laboratory and physical<br /><br>examination.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>