Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function (NCT05765344) | Clinical Trial Compass
CompletedPhase 1
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
United States74 participantsStarted 2023-03-15
Plain-language summary
The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
All individuals:
* Body mass index (BMI) of 18 ≤ BMI ≤ 40 kg/m\^2 at screening.
* Have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening.
* Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in the protocol.
* Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
* 12-lead electrocardiogram (ECG) evaluations at screening must be without clinically significant abnormalities as assessed by the investigator.
* Aside from hepatic impairment among the individuals with hepatic impairment, the individual must, in the opinion of the investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, and screening laboratory evaluations.
* Must be willing and able to comply with all study requirements.
Individuals With Hepatic Impairment:
* Have a diagnosis of chronic (\> 6 months), stable hepatic impairment (moderate or severe based upon the Child-Pugh-Turcotte (CPT) classification system for moderate o…
What they're measuring
1
Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
Timeframe: Day 6: Predose and up to 24 hours postdose
2
PK Parameter: Cmax,ss of BLV
Timeframe: Day 6: Predose and up to 24 hours postdose