Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
Completed · Phase 1
Conditions studied: Healthy Volunteer, Hepatic Impairment
In brief
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
Key facts
- Study ID
- NCT05724693
- Run by
- Atea Pharmaceuticals, Inc.
- People needed
- 39
- Starts
- 2023-01-30
- Expected to finish
- 2024-04-23
- Last updated by the study team
- 2024-07-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify 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 42.0 kg/m2
- Willing to comply with the study requirements and to provide written informed consent
- Subjects with Normal Hepatic Function (Groups 3 and 5):
- Medically healthy, in the opinion of an Investigator
- Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment
- Hepatic Impaired Subjects (Groups 1, 2, and 4):
- Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening
You may not qualify if…
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Other clinically significant medical conditions or laboratory abnormalities
- Hepatic Impaired Subjects (Groups 1, 2, and 4):
- Currently undergoing any method of dialysis
- History of liver transplant
- Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
- Evidence of hepatic carcinoma presence at Screening
Where it is running
- Atea Study Site Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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