Single-center, open label, multiple dose study to investigate the pharmacokinetics of RO5186582 given BID over 28 days, and in addition, the excretion and metabolism of [13C]- labelled IV microdoses and an oral [14C]-labelled dose of RO5186582 in Healthy Male Volunteers

Completed

• Conditions: Down Syndrome; trisomy 21; 10083624

• Registration Number: NL-OMON36981
• 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
30-55 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking or smoking < 5 cigarettes/day

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>Plasma levels of RO5186582 and its metabolites as appropriate, will be<br /><br>determined. Plasma concentrations will be determined by a validated assay. The<br /><br>stable isotope [13C]-labelled RO5186582 and RO5271857 will be measured in<br /><br>plasma by a specific LC/MS-MS method.<br /><br><br /><br>Radioactivity concentrations in blood, plasma, urine and feces will be<br /><br>determined by conventional methods and AMS as appropriate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination, C-SSRS and Leeds Sleep Questionnaire</p><br>