A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of ZPL389 following a single oral dose of [14C]ZPL389 in healthy male subjects.
Completed
- Conditions
- atopic dermatitis10040790
- Registration Number
- NL-OMON46218
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Healthy male subjects
18-55 yrs, inclusive
BMI: 18.0-30.0 kg/m2
Weigth at least 50kg
Non-smoking
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] ZPL389 - 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 of total radioactivity in blood and plasma.<br /><br><br /><br>To characterize the plasma pharmacokinetics of ZPL389.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of a single 100 mg oral dose of [14C]<br /><br>ZPL389 administered to healthy male subjects.</p><br>