A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LNP023 following a single oral dose of [14C]LNP023 in healthy male/female subjects.
Completed
- Conditions
- auto-immune diseases10003816
- Registration Number
- NL-OMON48316
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male / female of non-childbearing potential
18 - 55 years
more than 50 kilograms.
BMI 18.0 - 30.0 kilograms / meter2
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 plasma pharmacokinetics (PK) of LNP023 and key metabolites,<br /><br>if applicable.<br /><br>To determine the PK of total radioactivity in blood and plasma.<br /><br>To determine the rates and routes of excretion of [14C]LNP023-related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine and feces following a single 100-mg oral dose of [14C]LNP023 in healthy<br /><br>volunteers (HV).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of a single 100-mg oral dose of<br /><br>[14C]LNP023 administered to HV.</p><br>