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Also known as Aticaprant, Aticaprant Supratherapeutic Dose, Aticaprant Therapeutic Dose, 14C-aticaprant
JNJ-67953964 · 6 trials · 4 indications
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
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.
Screening pass rate of participants will be reported.
Assessment specific completion rate of participants will be reported.
The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors.
Change from baseline in QTc at each time point will be reported.
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 |
|---|---|---|
| Aticaprant | EXPERIMENTAL | Participants will receive Aticaprant 10 milligrams (mg) tablet orally, once daily for 42 days during double-blind (DB) treatment phase in addition to their current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo tablet orally, once daily for 42 days during DB treatment phase in addition to their current antidepressant SSRI/SNRI therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003. |
| 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. |
| Arm A: Aticaprant | EXPERIMENTAL | Participants will receive aticaprant during the double blind (DB) treatment phase. |
| Arm B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo during the DB treatment phase. |
| 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. |
| 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 |
|---|---|---|
| Aticaprant | DRUG | Aticaprant tablet will be administered orally. |
| Placebo | OTHER | Placebo tablet will be administered orally. |
| JNJ-67953964 | DRUG | JNJ-67953964 10 mg will be administered as two 5-mg 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. |
| 14C-aticaprant | DRUG | 14C-aticaprant will be administered orally as capsule on Day 1. |
Inclusion Criteria: * Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline * Have a Hamilton depression rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second scree...
JNJ-67953964 is an investigational small molecule being studied for the treatment of major depressive disorder. It is not approved for any indication and remains in clinical development. Johnson & Johnson is developing the compound, and the only reported trial enrolled adults with major depressive disorder.
JNJ-67953964 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The study was randomized, double-blind, and placebo-controlled, enrolling 181 participants. The drug has not been approved by the FDA or any other regulatory agency.
JNJ-67953964 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 2 trial evaluating the compound in major depressive disorder. No partnership or licensing details for this asset have been disclosed.
JNJ-67953964 has been evaluated in one completed Phase 2 trial, NCT03559192, titled "A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression." The trial enrolled 181 adults with major depressive disorder across the United States, Germany, Moldova, Russia, Ukraine, and the United Kingdom. No active trials are ongoing.
The Phase 2 trial NCT03559192 was a randomized, double-blind, placebo-controlled study of JNJ-67953964 in adults with major depressive disorder. It enrolled 181 participants of all sexes, aged 18 years and older, and did not include healthy volunteers. The trial has been completed.