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Also known as JNJ-67953964
14C-aticaprant · 2 trials · 2 indications
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.
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.
Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting.
Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.
Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.
| Arm | Type | Description |
|---|---|---|
| Lead-in Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for the entire duration of the lead-in period. |
| Treatment Period: JNJ-67953964 or Placebo | EXPERIMENTAL | Participants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2\*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks. |
| Withdrawal Period: Placebo | PLACEBO_COMPARATOR | Participants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study. |
| 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 |
|---|---|---|
| JNJ-67953964 | DRUG | JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily. |
| Placebo | DRUG | Matching placebo will be administered as 2 capsules orally once daily. |
| 14C-aticaprant | DRUG | 14C-aticaprant will be administered orally as capsule on Day 1. |
Inclusion Criteria: * Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI = weight/height\^2) * Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at scre...
14C-aticaprant is a carbon-14 labeled form of aticaprant, a small molecule developed by Johnson & Johnson. It is used in clinical research to study how the drug is absorbed, distributed, metabolized, and excreted in the human body. It is not a therapeutic product and is not approved for any medical use.
14C-aticaprant is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company conducted the clinical research on this radiolabeled compound.
14C-aticaprant has been studied in Phase 1 clinical development. It is an investigational research compound and is not FDA approved. The single Phase 1 trial has been completed.
14C-aticaprant has been evaluated in one completed Phase 1 trial, NCT05197062, titled A Study of 14C JNJ-67953964 in Healthy Adult Male Participants. The trial enrolled 8 healthy adult male participants in the Netherlands and was an uncontrolled study.
Yes, 14C-aticaprant is the carbon-14 labeled form of JNJ-67953964, also known as aticaprant. The trial NCT05197062 refers to the compound as 14C JNJ-67953964. The radiolabel allows researchers to track the drug and its metabolites through the body.