A randomized, double-blind, placebo- and active comparator-controlled, crossover trial to examine the effect of multiple doses of CVL-865 on panic symptoms induced by carbon dioxide inhalation in healthy subjects

Completed

Conditions: Panic disorder
anxiety disorder
10002861

Registration Number: NL-OMON49640

Lead Sponsor: Cerevel Therapeutics, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 54

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

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