Status and phase
Conditions
Treatments
About
The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
For All Participants
Additional Criteria for Participants With Normal Renal Function
Additional Criteria for Participants With Renal Impairment
Key Exclusion Criteria:
For All Participants
"Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
Serious risk of suicide in the opinion of the investigator is also exclusionary.
History of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the informed consent form (ICF).
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded.
Additional Criteria for Participants With Normal Renal Function
Additional Criteria for Participants With Renal Impairment
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
58 participants in 4 patient groups
Loading...
Central trial contact
Cerevel Clinical Trial Support
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal