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

July 29, 2024 updated by: Atea Pharmaceuticals, Inc.

A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of AT-527 in Adult Subjects With Normal and Impaired Renal Function Sub-Study: Effects of Probenecid on the Pharmacokinetics of AT-527 in Healthy Adult Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Québec, Canada
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A-Mild Renal Impairment
single dose AT-527
Drug: AT-527
single dose AT-527
Other Names:
  • Bemnifosbuvir
Drug: AT-527
Single dose of AT-527 pre- and post-dialysis
Other Names:
  • Bemnifosbuvir
Experimental: Group B-Moderate Renal Impairment
single dose AT-527
Drug: AT-527
single dose AT-527
Other Names:
  • Bemnifosbuvir
Drug: AT-527
Single dose of AT-527 pre- and post-dialysis
Other Names:
  • Bemnifosbuvir
Experimental: Group C-Severe Renal Impairment (optional)
single dose AT-527
Drug: AT-527
single dose AT-527
Other Names:
  • Bemnifosbuvir
Drug: AT-527
Single dose of AT-527 pre- and post-dialysis
Other Names:
  • Bemnifosbuvir
Experimental: Group D-End-Stage Renal Disease (optional)
single dose of AT-527 pre- and post-dialysis
Drug: AT-527
single dose AT-527
Other Names:
  • Bemnifosbuvir
Drug: AT-527
Single dose of AT-527 pre- and post-dialysis
Other Names:
  • Bemnifosbuvir
Experimental: Group E-Matched Healthy Subjects
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Drug: AT-527 and Probenecid
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Other Names:
  • Bemnifosbuvir

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
Time Frame: Day 1
Day 1
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Time Frame: Day 1
Day 1
Pharmacokinetics (PK) of AT-527 AUC
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT-03A-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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