A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMIC EFFECTS, SAFETY AND TOLERABILITY OF REPEATED DOSING OF RO5459072 IN HEALTHY SUBJECTS

Completed

• Conditions: Lupus; 10003816

• Registration Number: NL-OMON42481
• 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: 36

Inclusion Criteria

Healthy male and female subjects
18 to 60 years old, iinclusive
BMI between 18.0 and 30.0 kg/m^2

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 investigate the effects of RO5459072 on pharmacodynamic measures of<br /><br>cathepsin S activity and immune function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To investigate the safety and tolerability of repeated dosing with RO5459072.<br /><br>* To characterize the steady state pharmacokinetics of RO5459072 and assess<br /><br>time dependency.<br /><br>* To characterize the relationship between RO5459072 exposure and<br /><br>pharmacodynamic parameters<br /><br>* To explore the influence of intrinsic factors and alternative dosing regimens<br /><br>on the pharmacokinetics and pharmacodynamic effects of RO5459072.<br /><br>* To collect samples for exploratory metabolite profiling.</p><br>