Status and phase
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About
The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
All Participants
Additional Inclusion Criteria for Participants With Normal Hepatic Function
Additional Inclusion Criteria for Participants With Hepatic Impairment - Participants with stable hepatic impairment that meets the criteria for Class A, Class B, or Class C of the modified Child-Pugh Classification. Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
Key Exclusion Criteria:
For All Participants
Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
Have recently been diagnosed with symptomatic coronavirus disease 2019 (COVID-19) or test positive for SARS-CoV-2 within 15 days prior to signing the informed consent form (ICF).
Positive drug screen or a positive test for alcohol at Screening or Baseline (Check-in/Day -1) Visits.
Use of prohibited medications prior to randomization or likely to require prohibited concomitant therapy during the trial.
Current use of tobacco or nicotine-containing products (cigarettes, cigars, chewing tobacco, snuff, e-cigarettes, etc). Note: Light smokers (<5 cigarettes/day or equivalent) are allowed provided they abstain from the use of tobacco- or nicotine-containing products for at least 2 hours prior to PK assessments.
Known allergy or hypersensitivity to the investigational medicinal product (IMP), closely related compounds, or any of their specified ingredients.
Has received IMP in a clinical trial of emraclidine within 12 months of signing the ICF.
Participants with a 12-lead ECG demonstrating any of the following at the Screening Visit and at Check-in (Day -1):
Blood pressure measurements demonstrating any of the following at the Screening Visit and/or at Check-in (Day -1):
Additional Exclusion Criteria for Participants with Hepatic Impairment
Primary purpose
Allocation
Interventional model
Masking
40 participants in 4 patient groups
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Central trial contact
María Inés Enei
Data sourced from clinicaltrials.gov
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