Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely I… (NCT06911320) | Clinical Trial Compass
RecruitingPhase 1
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
United States28 participantsStarted 2025-04-09
Plain-language summary
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* BMI of 18.5 to 43.0 kg/m2
* Willing to comply with the study requirements and to provide written informed consent
Renal Impaired Subjects (Group 1):
* Considered stable in the judgement of an Investigator
* Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min)
Hepatic Impaired Subjects (Group 2):
* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).
Subjects with Normal Hepatic and Renal Function (Group 3):
* Medically healthy, in the opinion of an Investigator
* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment
Exclusion Criteria:
* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus or HIV
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Renal and Hepatic Impaired Subjects (Group 1 and 2):
* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \> 10%
* Undergoing any method of dialysis
* Subjects requiring treatm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
Timeframe: Day 1
2
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)