A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state.
Completed
- Conditions
- autoimmune and chronic inflammatory diseases10003816
- Registration Number
- NL-OMON49324
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
healthy male or female of non-childbearing potential.
18 - 55 years of age.
BMI 18.0 - 30.0 kilograms/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>To determine the rates and routes of excretion of [14C]LOU064-related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine and feces.<br /><br><br /><br>To determine the pharmacokinetics (PK) of total radioactivity in blood and<br /><br>plasma of [14C]LOU064.<br /><br><br /><br>To characterize the blood PK of LOU064 and known key metabolites, if<br /><br>applicable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of multiple oral doses of 100 mg of<br /><br>LOU064 administered to healthy male/female subjects.</p><br>