A single-center, randomized, double-blind, placebo-controlled, single ascending dose study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of single doses of RO5459072 in healthy volunteers.
Completed
- Conditions
- Lupus10003816
- Registration Number
- NL-OMON41854
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Healthy subjects
18 and 60 years of age, inclusive
BMI 18 - 30 kilogram/meter2
non smokers
*
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>Primary: To investigate the safety and tolerability of RO5459072 in healthy<br /><br>volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>* To investigate the effects of RO5459072 on pharmacodynamic measures of<br /><br>cathepsin S activity.<br /><br>* To characterize the relationship between RO5459072 exposure and<br /><br>pharmacodynamic measures of cathepsin S activity.<br /><br>* To characterize the single dose pharmacokinetics of RO5459072 and assess dose<br /><br>proportionality.<br /><br>* To explore the influence of genotype on the pharmacokinetic and<br /><br>pharmacodynamic effects of RO5459072.<br /><br>* To collect samples for exploratory metabolite profiling.</p><br>