Study of AT-527 in Subjects With Normal and Impaired Renal Function
Healthy Volunteer, Renal Impairment
About this trial
This is an interventional treatment trial for Healthy Volunteer
Eligibility Criteria
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 42.0 kg/m2 Willing to comply with the study requirements and to provide written informed consent Subjects with Normal Renal Function (Group E): Medically healthy, in the opinion of an Investigator Normal renal function with eGFR ≥ 90 mL/min/1.73m2 at Screening Renal Impaired Subjects (Groups A, B, and C): Considered stable in the judgement of an Investigator Presence of severe renal impairment (eGFR ≥ 15 and < 30 mL/min/1.73m2), moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73m2) or mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73m2) at Screening: renal impairment should have been stable for at least 1 month prior to Screening. Subjects with End-Stage Renal Disease -ESRD (Group D) Considered clinically stable in the opinion of the Investigator Presence of ESRD (eGFR <15 mL/min/1.73m2 and being on intermittent hemodialysis) at Screening and have been stable for at least 1 month prior to Screening Exclusion Criteria: Pregnant or breastfeeding Infected with 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 Subjects with Normal Renal Function (Group E): • Any clinically significant illness in the opinion of the investigator Subjects with Impaired Renal Function (Group A, B, C and D): History of renal transplant Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10% Subjects requiring treatment for renal impairment or other chronic disease must be on a stable treatment plan
Sites / Locations
- Atea Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group A-Mild Renal Impairment
Group B-Moderate Renal Impairment
Group C-Severe Renal Impairment (optional)
Group D-End-Stage Renal Disease (optional)
Group E-Matched Healthy Subjects
single dose AT-527
single dose AT-527
single dose AT-527
single dose of AT-527 pre- and post-dialysis
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19