Healthy Volunteer, Renal Impairment
Conditions
Brief summary
Study of AT-527 in Subjects with Normal and Impaired Renal Function
Interventions
DRUGAT-527
single dose AT-527
DRUGAT-527 and Probenecid
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax) | Day 1 |
| Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC) | Day 1 |
| Pharmacokinetics (PK) of AT-527 AUC | Day 1 |
Countries
Canada
Outcome results
None listed