anxiety disorder Panic disorder
Conditions
Interventions
Test:
CVL-865 7.5 mg (BID)
CVL-865 25 mg (BID)
Alprazolam with extended release 1 mg (BID)
Sponsors
Cerevel Therapeutics, LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects, ages 18 to 55 years, inclusive, at the time of signing the ICF. 3. A female subject of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent and for 30 days post last dose. A male subject with a pregnant or a nonpregnant partner of childbearing potential must agree to use condom during treatment and until the end of relevant systemic exposure in the male subject for 94 days following the last dose with IMP. 6. Defined as sensitive to the anxiogenic effects of double-breath CO2 inhalation as defined in the protocol section 4.1.
Exclusion criteria
Exclusion criteria: 1. Subjects with a current history of clinically significant cardiovascular (eg, history or suspicion of infarct, cardiomyopathy, cardiac failure, transient ischemic attack, angina pectoris, cardiac arrhythmias, or cerebrovascular accident), pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial. 2. Subjects with a current or past history of clinically significant respiratory conditions, including asthma, lung fibrosis, and non-invalidating chronic obstructive pulmonary disease. 3. Subject with a personal or family history of sickle cell anemia. 4. Subject with a personal or family history of cerebral aneurysm. 5. Subjects with a clinically significant current or past personal or family history of any psychiatric disorder as classified by DSM-4 or DSM-5 criteria. 27. Subjects that test positive for a SARS-CoV-2 infection on day -1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the PSL-IV score from pre-CO2 to post-CO2 challenge value. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS Fear score from pre-CO2 to post-CO2 challenge value. Change from pre-CO2 to post-CO2 challenge values in vital sign measurements (systolic blood pressure, diastolic blood pressure, heart rate) related to the physiological response to CO2 inhalation challenge using Finapres Assessment. Treatment-emergent AEs, clinically significant changes in ECGs, clinical laboratory assessments, vital sign measurements, and physical and neurological examination results. Suicidality assessed using the C-SSRS. Summary listing of CVL-865 (and alprazolam, if appropriate) concentrations by dose and time point. Change from baseline in NeuroCart assessments: o Saccadic eye movements (saccadic reaction time, saccadic peak velocity [deg/sec], and saccadic inaccuracy) o Body sway (antero-posterior sway [mm/2 minutes]) o Adaptive tracking (%) o Bond & Lader VAS (alertness, calmness, mood subscales [mm]) o Quantitative EEG | — |
Countries
Netherlands
Outcome results
None listed