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Also known as JNJ-67953964
Aticaprant Supratherapeutic Dose · 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.
Change from baseline in QTc at each time point will be reported.
| 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. |
| Treatment Sequence 1 | EXPERIMENTAL | Healthy participants will receive single oral dose of Aticaprant (Dose 1) (Treatment A) in Treatment Period 1, followed by Moxifloxacin (Dose 2) (Treatment D) in Treatment Period 2, followed by Aticaprant (Dose 3) (Treatment B) in Treatment Period 3 and then placebo (Treatment C) in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 2 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 and then Treatment D in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 3 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3 and then Treatment A in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 4 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment D in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 and then Treatment B in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7 to 15 days between each treatment period. |
| 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. |
| Aticaprant Supratherapeutic Dose | DRUG | Aticaprant supratherapeutic dose capsule will be administered orally. |
| Aticaprant Therapeutic Dose | DRUG | Aticaprant therapeutic dose capsule will be administered orally. |
| Moxifloxacin | DRUG | Moxifloxacin capsule will be administered orally. |
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...
Aticaprant Supratherapeutic Dose refers to a high-dose formulation of aticaprant studied by Johnson & Johnson in a Phase 1 clinical trial. The trial evaluated the cardiac safety profile of the supratherapeutic dose in healthy adult volunteers. Aticaprant is a small molecule drug candidate.
Aticaprant Supratherapeutic Dose targets OPRK1, the kappa opioid receptor. It acts as an antagonist at this receptor. The supratherapeutic dose formulation was designed to test the drug at higher exposure levels than standard dosing in a dedicated cardiac safety study.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of Aticaprant Supratherapeutic Dose. The company sponsored the Phase 1 thorough QT study of the compound, also known as JNJ-67953964, in healthy adult participants.
Aticaprant Supratherapeutic Dose is in Phase 1 clinical development. It is an investigational drug candidate and has not been approved by the FDA. The single completed Phase 1 trial enrolled 60 healthy adult participants and was conducted in Belgium.
Aticaprant Supratherapeutic Dose has been studied in one completed Phase 1 trial, NCT05387759, titled A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants. The randomized, double-blind, controlled trial enrolled 60 healthy volunteers in Belgium to assess cardiac safety.
Yes, Aticaprant Supratherapeutic Dose is the same compound as JNJ-67953964. JNJ-67953964 is the internal code designation used by Johnson & Johnson for aticaprant. The supratherapeutic dose refers to the high-dose formulation evaluated in the Phase 1 thorough QT study.