A phase 1, open-label study to characterize the absorption, metabolism, and excretion of 14C-JNJ-53718678 after a single oral dose in healthy adult male subjects
Completed
- Conditions
- RSV10047438
- Registration Number
- NL-OMON43122
- Lead Sponsor
- Janssen Sciences Ireland UC
- 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 to 30.0 kg/m2, extremes included
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Subject has received an experimental drug or experimental vaccine, or has used an experimental medical device within 1 month or within a period less than 10 times the drug*s half-life, whichever is longer, before scheduled study drug administration. Subject has donated blood or blood products or has had substantial loss of blood within 3 months before study drug administration or intention to donate blood or blood products during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- to determine the routes of excretion for JNJ-53718678 and its metabolites<br /><br>after administration of a single oral dose of 14C-JNJ-53718678 in healthy adult<br /><br>male subjects<br /><br>- to explore the metabolic pathways of JNJ-53718678 after administration of a<br /><br>single oral dose of 14C-JNJ-53718678 in healthy adult male subjects<br /><br>- to determine the chemical structure of predominant metabolites</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine safety and tolerability of a single oral dose of 14CJNJ- 53718678<br /><br>in healthy adult male subjects.</p><br>