About this trial
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m²) (inclusive).
Able to provide written, informed consent.
Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.
Otherwise be in generally good health.
Disqualifiers
Participants who are breastfeeding.
Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
Participants with international normalized ratio (INR) greater than (>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.
Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
Trial design
Parallel
Treatments tested in this trial
Repinatrabit
DrugOral tablet
Treatment groups
Trial outcomes
Primary outcomes
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
Secondary outcomes
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Sponsors and contacts
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