Depression
Conditions
Interventions
14C-radioactively labeled aticaprant once
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PK, metabolism, and routes of excretion of aticaprant and its metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine safety and tolerability | — |
Countries
Netherlands
Outcome results
None listed