Approval Probability
TA Base Rate
Adjusted LOA
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Also known as Icalcaprant, ABBV-1354
CVL-354 · 4 trials · 5 indications
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Cmax of ABBV-1354 will be assessed.
Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
AUCt of ABBV-1354 will be assessed.
AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
| Arm | Type | Description |
|---|---|---|
| Group 1: Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks. |
| Group 2: Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks. |
| Group 3: Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks. |
| Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| ABBV-1354 | EXPERIMENTAL | Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. |
| Name | Type | Description |
|---|---|---|
| Icalcaprant | DRUG | Oral Capsules |
| Placebo for Icalcaprant | DRUG | Oral Capsules |
| CVL-354 | DRUG | Oral solution/capsule |
| [11C]-LY2795050 | DRUG | IV injection |
| [11C]-carfentanil | DRUG | IV injection |
| ABBV-1354 | DRUG | Oral solution |
Inclusion Criteria: * Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 months prior to Screening. * Body Mass Index (...
CVL-354 is an investigational small molecule being developed by AbbVie Inc. for opioid use disorder. It is a Phase 1 candidate that has been studied in a positron emission tomography trial to evaluate target occupancy at kappa and mu opioid receptors in the brain following oral dosing.
CVL-354 is being developed for the treatment of opioid use disorder. It is an investigational therapy and has not been approved for any indication. The clinical program to date has focused on evaluating its activity at opioid receptors in the brain.
CVL-354 targets the kappa opioid receptor, or KOR, a receptor involved in brain signaling. Its Phase 1 PET trial also evaluated occupancy at mu opioid receptors. The study measured target occupancy at both kappa and mu opioid receptors following oral dosing.
CVL-354 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for the drug in opioid use disorder.
CVL-354 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The completed Phase 1 trial enrolled 19 participants and evaluated target occupancy at kappa and mu opioid receptors.
CVL-354 has been studied in one completed Phase 1 trial, NCT05547542, titled a positron emission tomography trial to evaluate target occupancy of CVL-354 at kappa and mu opioid receptors in the brain following oral dosing. The trial enrolled 19 participants and was conducted in opioid use disorder.