PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral Dosing (NCT04787302) | Clinical Trial Compass
CompletedPhase 1
PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral Dosing
United States, Belgium15 participantsStarted 2021-06-01
Plain-language summary
PET Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Oral Dosing
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 55 years, inclusive, at the time of signing the ICF
* Sexually active men with a pregnant or a nonpregnant partner of childbearing potential must agree to use a double-barrier method of birth control, including a condom, and practice contraception during treatment and through 7 days post dose
* Capable of providing informed consent and following study requirements
Exclusion Criteria:
* Subjects who answer yes on the C-SSRS or, in the opinion of the investigator, present a serious risk of suicide
* Subjects with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease
* Subjects with a 12-lead ECG demonstrating either of the following (average of 3 ECGs obtained at the Screening Visit):
* QT interval corrected for heart rate using Fridericia's formula \>450 msec
* Left ventricular hypertrophy
* Orthostatic hypotension, which is defined as a decrease of ≥20 mmHg in systolic blood pressure and/or a decrease of ≥10 mmHg in diastolic blood pressure after at least 3 minutes of standing compared with the immediately previous supine/semi-recumbent blood pressure at Screening or at the prescan time point prior to baseline PET scan.
* Subjects with a current or past personal history of any psychiatric disorder as classified by DSM-5 criteria or immediate family members with …
What they're measuring
1
M4 receptor occupancy in the striatum following single oral doses of CVL-231 in healthy adult subjects