Single-center, open-label, non-randomized study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO5285119 in healthy male subjects

Completed

• Conditions: ASD; Asperger's syndrome; Autism Disorder; 10029305

• Registration Number: NL-OMON41196
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

healthy male subjects
35-64 yrs, inclusive
BMI: 18.0 - 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 90 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>To characterize the routes and rates of elimination of [14C]-labeled RO5285119<br /><br>To assess the pharmacokinetics of total drug related material, RO5285119 and<br /><br>its metabolite(s) as appropriate</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To identify and quantify the metabolic profiles of RO5285119 in plasma, feces<br /><br>and urine, based on radioactive metabolic profiling, and characterize any major<br /><br>metabolite(s)<br /><br>To explore the safety and tolerability of a single dose of RO5285119 in healthy<br /><br>volunteers</p><br>