Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005130-42 | EudraCT Number | ||
| 67953964MDD1002 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose 14C-aticaprant in healthy adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-aticaprant | Experimental | Participants in Group A (without duodenal fluid collection) and Group B (with duodenal fluid collection) will receive a single oral dose of 14C-aticaprant on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-aticaprant | Drug | 14C-aticaprant will be administered orally as capsule on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Aticaprant and its Metabolite M3 | Plasma samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a validated, specific, and sensitive liquid chromatography (LC)-mass spectrometry (MS)/MS method. | Up to Day 39 |
| Duodenal Concentrations of Aticaprant and its Metabolite M3 | Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method. | Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1 |
| Urine Concentration of Aticaprant and its Metabolites M3 | Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method. | Pre-dose up to Day 32 |
| Total Radioactivity Concentration of 14C-aticaprant in Whole Blood | Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting. | Pre-dose up to Day 14 |
| Total Radioactivity Concentration of 14C-aticaprant in Plasma | Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting. | Pre-dose up to Day 14 |
| Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid | Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting. | Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to Day 67 |
| Number of Participants with Clinical Laboratory Abnormalities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | NZ 9728 | Netherlands |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000590915 | Aticaprant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amount of Total Radioactivity of 14C-aticaprant in Urine | Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting. | Up to Day 32 |
| Amount of Total Radioactivity of 14C-aticaprant in Feces | Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting. | Up to Day 32 |
Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported. |
| Up to Day 67 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Number of participants with ECG abnormalities will be reported. | Up to Day 67 |
| Number of Participants with Vital Signs Abnormalities | Number of participants with vital signs abnormalities (including body temperature, pulse rate, respiratory rate, blood pressure [systolic and diastolic]) will be reported. | Up to Day 67 |
| Number of Participants with Physical Examination Abnormalities | Number of participants with physical examination abnormalities will be reported. | Up to Day 67 |