Study of AT-527 in Subjects With Normal and Impaired Renal Function

Study of AT-527 in Subjects with Normal and Impaired Renal Function

Inclusion Criteria:Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drugFemales must have a negative pregnancy test at Screening and prior to dosingBMI of 18.5 to 42.0 kg/m2Willing to comply with the study requirements and to provide written informed consentSubjects with Normal Renal Function (Group E):Medically healthy, in the opinion of an InvestigatorNormal renal function with eGFR ≥ 90 mL/min/1.73m2 at ScreeningRenal Impaired Subjects (Groups A, B, and C):Considered stable in the judgement of an InvestigatorPresence 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 InvestigatorPresence 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 ScreeningExclusion Criteria:Pregnant or breastfeedingInfected with HIV or COVID-19Abuse of alcohol or drugsUse of other investigational drugs within 28 days of dosingOther clinically significant medical conditions or laboratory abnormalitiesSubjects with Normal Renal Function (Group E):• Any clinically significant illness in the opinion of the investigatorSubjects with Impaired Renal Function (Group A, B, C and D):History of renal transplantPresence 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