Genesis Clinical Research | Tampa, FL
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About
The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
All Individuals:
Individuals with Renal Impairment (RI):
Have RI classification at screening that has been unchanged during the 90 days prior to study drug dosing.
Estimated Glomerular Filtration Rate (eGFR) must be the following (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Inker 2021)) based on serum creatinine as measured at the screening evaluation:
Hemoglobin ≥ 9 g/dL at screening.
Individuals with cardiovascular disease, hypertension, diabetes mellitus, hyperlipidemia, hypothyroidism, osteoporosis, and many others) may be included provided that these diseases/conditions are clinically stable.
Matched Control Individuals:
Key Exclusion Criteria:
All Individuals:
Individuals with RI:
Matched Control Individuals:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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