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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral tablet
Panax Clinical Research
Miami, Florida, United States
RECRUITINGGroups 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
Time frame: From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
Time frame: From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
Time frame: From Day 1 to Day 8
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
Time frame: Up to Day 14
All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results
Time frame: Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Time frame: Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Time frame: Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results
Time frame: Up to Day 8
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