Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-06852231, Emraclidine, ABBV-1231
CVL-231 · 9 trials · 6 indications
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.
Cmax of Emraclidine
Tmax of Emraclidine
AUCt of Emraclidine
AUCtau of Emraclidine
Cmin of Emraclidine
Cavg of Emraclidine
Terminal phase elimination half-life of Emraclidine
λz of Emraclidine
CL/F of Emraclidine
Vz/F of Emraclidine
PTR of Emraclidine
RacCmax of Emraclidine
RacAUCtau of Emraclidine
Cmax of Metabolite (CV-0000364)
AUCtau of Metabolite (CV-000036)
Tmax of Metabolite (CV-0000364)
AUCt of Metabolite (CV-000036)
MRCmax of Metabolite (CV-000036)
MRAUCtau of Metabolite (CV-0000364)
Terminal phase elimination half-life of Metabolite (CV-0000364)
λz of Metabolite (CV-0000364)
PTR of Metabolite (CV-0000364)
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Cmax of Emraclidine
Tmax of Emraclidine
AUCt of Emraclidine
AUCtau of Emraclidine
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status.
The BARS consists of 4 items related to akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Extrapyramidal symptoms will be evaluated using SAS, AIMS, and BARS scales.
| Arm | Type | Description |
|---|---|---|
| Emraclidine Part A | EXPERIMENTAL | Participants will be assigned to receive one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Placebo-Part A | EXPERIMENTAL | Participants will be assigned to receive one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Emraclidine-Part B | EXPERIMENTAL | Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. |
| Placebo-Part B | EXPERIMENTAL | Participants will receive placebo for 42 days followed by a 30-day safety follow-up period. |
| CVL-231 15 mg, once daily (QD) | EXPERIMENTAL | Oral Dose |
| CVL-231 30 mg, once daily (QD) | EXPERIMENTAL | Oral Dose |
| Placebo, once daily (QD) | PLACEBO_COMPARATOR | Oral Dose |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6. |
| Emraclidine 10 mg, once daily (QD) | EXPERIMENTAL | Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6. |
| Emraclidine 30 mg, once daily (QD) | EXPERIMENTAL | Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6. |
| Mild Renal Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
| Normal Renal Function | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
| Severe Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 milligrams (mg) emraclidine. |
| Moderate Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine. |
| Mild Hepatic Impairment | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine. |
| Normal Hepatic Function | EXPERIMENTAL | Participants will receive a single oral dose of 10 mg emraclidine. |
| Part A: Cohort 1: Emraclidine Dose 1 | EXPERIMENTAL | Participants will receive emraclidine dose 1 or emraclidine-matching placebo tablets, orally, once daily (QD) up to Day 14. |
| Part A: Cohort 2: Emraclidine Dose 2 | EXPERIMENTAL | Participants will receive emraclidine dose 2 or emraclidine-matching placebo tablets, orally, QD up to Day 14. |
| Part A: Cohort 3: Emraclidine Dose 3 | EXPERIMENTAL | Participants will receive emraclidine dose 3 or emraclidine-matching placebo tablets, orally, QD up to Day 14. |
| Part A: Cohort 4: Emraclidine Dose 4 | EXPERIMENTAL | Participants will receive emraclidine dose 4 or emraclidine-matching placebo tablets, orally, QD up to Day 14. |
| Part A: Cohort 5: Emraclidine Dose 5 | EXPERIMENTAL | Participants will receive emraclidine dose 5 or emraclidine-matching placebo tablets, orally, QD up to Day 14. |
| Part B: Cohort 6: Emraclidine Dose 6 | EXPERIMENTAL | Participants with dementia due to AD will receive emraclidine dose 6 or emraclidine-matching placebo tablets, orally, QD up to Day 28. |
| Name | Type | Description |
|---|---|---|
| Emraclidine | DRUG | Oral Tablets |
| Placebo | DRUG | Oral Tablets |
| Emraclidine 15 mg | DRUG | Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks |
| Emraclidine 30 mg | DRUG | Emraclidine 30 mg, oral (tablet), QD for 6 weeks |
| Emraclidine 10 mg | DRUG | Emraclidine 10 mg, oral (tablet), once per day for 6 weeks |
| CVL-231 | DRUG | CVL-231 |
| Matching Placebo | DRUG | Placebo matching CVL-231 |
Inclusion Criteria: * BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight \> 50 kg (110 lbs). * (Part A only): Positive and Negative Syndrome Scale (PANSS) total score \< 80 at Screening and at Baseline * (Part B only): Participant experiencing an acute exacerbation of psychotic s...
CVL-231 is an investigational small molecule being developed for schizophrenia and for blood pressure effects in people with schizophrenia. It is in Phase 1 clinical development and is not yet approved by the FDA.
CVL-231 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting Phase 1 clinical trials to evaluate the drug in schizophrenia and related blood pressure measures.
CVL-231 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with no active trials currently listed.
CVL-231 has completed three Phase 1 trials: NCT04136873, a multiple ascending dose trial in schizophrenia; NCT04787302, a PET trial measuring brain receptor occupancy; and NCT05245539, a trial of its effect on 24-hour ambulatory blood pressure in schizophrenia participants.
No alternative names for CVL-231 have been disclosed. It is referred to only as CVL-231 in clinical trial records and by its developer, AbbVie Inc.