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Official title Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
ClinicalTrials.gov ID: NCT06911320
What this study is testing
What is Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination?
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination is an investigational medicine, being studied as a potential treatment for healthy volunteer study.
Also referred to as AT-527 (BEM) and AT-038 (RZR).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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 people (Group 1):
- Considered stable in the judgement of an Investigator
You likely can't join if
- 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 people (Group 1 and 2):
- Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \> 10%
See the full eligibility 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 people (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 people (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). people 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 people with severe renal and hepatic impairment
- 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 people (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
- people requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan Renal Impaired people (Group 1):
- History of renal transplant
- Concurrent use of medications known to affect the elimination of serum creatinine Hepatic Impaired people (Group 2):
- History of liver transplant
- Evidence of hepatic carcinoma presence at Screening
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.