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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2024-06-15

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteer Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A-Mild Renal Impairment

single dose AT-527

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

single dose AT-527

Group B-Moderate Renal Impairment

single dose AT-527

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

single dose AT-527

Group C-Severe Renal Impairment (optional)

single dose AT-527

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

single dose AT-527

Group D-End-Stage Renal Disease (optional)

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

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

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

Group E-Matched Healthy Subjects

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

Group Type EXPERIMENTAL

AT-527 and Probenecid

Intervention Type DRUG

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

Interventions

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AT-527

single dose AT-527

Intervention Type DRUG

AT-527

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

Intervention Type DRUG

AT-527 and Probenecid

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

Intervention Type DRUG

Other Intervention Names

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Bemnifosbuvir Bemnifosbuvir Bemnifosbuvir

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes