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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy Volunteer

Treatments: Drug: AT-527 and Probenecid; Drug: AT-527

Study type: Interventional

Funder types: Industry

Identifiers

NCT05618314

AT-03A-011

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 5 patient groups

Group A-Mild Renal Impairment

Experimental group

Description:

single dose AT-527

Treatment:

Drug: AT-527

Drug: AT-527

Group B-Moderate Renal Impairment

Experimental group

Description:

single dose AT-527

Treatment:

Drug: AT-527

Drug: AT-527

Group C-Severe Renal Impairment (optional)

Experimental group

Description:

single dose AT-527

Treatment:

Drug: AT-527

Drug: AT-527

Group D-End-Stage Renal Disease (optional)

Experimental group

Description:

single dose of AT-527 pre- and post-dialysis

Treatment:

Drug: AT-527

Drug: AT-527

Group E-Matched Healthy Subjects

Experimental group

Description:

Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19

Treatment:

Drug: AT-527 and Probenecid