Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-radio-labeled RO4602522 in Healthy Male Volunteers

Completed

• Conditions: dementia; 10029305; Alzheimer's disease

• Registration Number: NL-OMON36882
• Lead Sponsor: Hoffmann-La Roche

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
35-55 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, 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 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:<br /><br>Bloodsamples for the analysis of RO4602522 and amount of radioactivity will be<br /><br>collected during the clinic period.<br /><br>Urine and feces for the analysis of RO4602522 and amount of radioactivity will<br /><br>be collected during the clinic period and, if required, after leaving the<br /><br>clinic until at maximum 20 days after dosing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Blood, urine, and feces samples for the analysis of the metabolic profile of<br /><br>RO4602522 will be collected during the clinic period.</p><br>