Healthy VolunteerPhase 1NCT05618314
Study of AT-527 in Subjects With Normal and Impaired Renal Function
A Phase 1 study testing AT-527 and AT-527 and Probenecid in people with Healthy Volunteer and Renal Impairment, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Study of AT-527 in Subjects with Normal and Impaired Renal Function Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Renal Impairment
- What is being tested?
- AT-527 and AT-527 and Probenecid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2022to 15 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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):
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Healthy Volunteer, Renal Impairment
- Being tested
- AT-527, AT-527 and Probenecid
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527Drug
Also called Bemnifosbuvir
single dose AT-527
AT-527Drug
Also called Bemnifosbuvir
Single dose of AT-527 pre- and post-dialysis
AT-527 and ProbenecidDrug
Also called Bemnifosbuvir
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
| Study group | Role | What they receive |
|---|---|---|
| Group A-Mild Renal Impairment | Experimental | single dose AT-527 Receives: Drug: AT-527 |
| Group B-Moderate Renal Impairment | Experimental | single dose AT-527 Receives: Drug: AT-527 |
| Group C-Severe Renal Impairment (optional) | Experimental | single dose AT-527 Receives: Drug: AT-527 |
| Group D-End-Stage Renal Disease (optional) | Experimental | single dose of AT-527 pre- and post-dialysis Receives: Drug: AT-527 |
| Group E-Matched Healthy Subjects | Experimental | Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19 Receives: Drug: AT-527 and Probenecid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
Measured: Day 1
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Measured: Day 1
Pharmacokinetics (PK) of AT-527 AUC
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start17 Oct 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618314
- Sponsor's protocol ID
- AT-03A-011
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05618314
- Acronym / sponsor ID
- AT-03A-011
- Conditions
- Healthy Volunteer, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of AT-527 in Subjects with Normal and Impaired Renal Function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A-Mild Renal Impairment | Experimental | Drug: AT-527single dose AT-527 |
| Group B-Moderate Renal Impairment | Experimental | Drug: AT-527single dose AT-527 |
| Group C-Severe Renal Impairment (optional) | Experimental | Drug: AT-527single dose AT-527 |
| Group D-End-Stage Renal Disease (optional) | Experimental | Drug: AT-527single dose of AT-527 pre- and post-dialysis |
| Group E-Matched Healthy Subjects | Experimental | Drug: AT-527 and ProbenecidSingle dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Medically healthy, in the opinion of an Investigator
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-527Also: Bemnifosbuvirsingle dose AT-527 | Drug | Group A-Mild Renal Impairment, Group B-Moderate Renal Impairment, Group C-Severe Renal Impairment (optional) |
| AT-527Also: BemnifosbuvirSingle dose of AT-527 pre- and post-dialysis | Drug | Group D-End-Stage Renal Disease (optional) |
| AT-527 and ProbenecidAlso: BemnifosbuvirSingle dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19 | Drug | Group E-Matched Healthy Subjects |
Primary outcome
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
Time frame: Day 1
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Time frame: Day 1
Pharmacokinetics (PK) of AT-527 AUC
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT-527 and AT-527 and Probenecid in people with Healthy Volunteer and Renal Impairment, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.