A Phase 1, Open Label Study to Characterize the Absorption, Metabolism, and Excretion of 14C JNJ 67953964 After a Single Dose in Healthy Adult Male Participants
- Conditions
- Depression10027946
- Registration Number
- NL-OMON51737
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
-18 to 55 years of age, inclusive.
-Healthy on the basis of physical examination, medical history (screening
only), vital signs, and ECG performed at screening and admission to the study
site on Day -1.
-Healthy on the basis of clinical laboratory tests performed at screening and
at admission to the study center.
-Body weight not less than 50 kg and body mass index (BMI; weight [kg]/height2
[m]2) within the range of 18.0 to 29.9 kg/m2 (inclusive).
-Male
-A male participant during the study and for a minimum of 1 spermatogenesis
cycle (defined as approximately 90 days) after receiving the last dose of study
intervention.
1. History of or current clinically significant medical illness including (but
not limited to) cardiac arrhythmias or other cardiac disease, hematologic
disease, coagulation disorders , lipid abnormalities, significant pulmonary
disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease,
neurologic or psychiatric disease, infection, or any other illness.
2. History of malignancy within 5 years before screening.
3. Known allergies, hypersensitivity, or intolerance to aticaprant or its
excipients.
4. Participant has clinically relevant GI complaints per clinical judgment at
screening or baseline or history of documented gastric disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the PK, metabolism, and routes of excretion of aticaprant and its<br /><br>metabolites</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine safety and tolerability</p><br>