Healthy VolunteerPhase 1NCT05724693
Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
A Phase 1 study testing Bemnifosbuvir (BEM) in people with Healthy Volunteer and Hepatic Impairment, run by Atea Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose 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, Hepatic Impairment
- What is being tested?
- Bemnifosbuvir (BEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 23 Apr 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 Hepatic Function (Groups 3 and 5):
- Medically healthy, in the opinion of an Investigator
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- Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment
- Hepatic Impaired Subjects (Groups 1, 2, and 4):
- Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening
Who cannot join
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, 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
- Hepatic Impaired Subjects (Groups 1, 2, and 4):
Show all 10Show fewer
- Currently undergoing any method of dialysis
- History of liver transplant
- Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
- Evidence of hepatic carcinoma presence at Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Atea Study Site Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
- Conditions
- Healthy Volunteer, Hepatic Impairment
- Being tested
- Bemnifosbuvir (BEM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemnifosbuvir (BEM)Drug
Also called AT-527
Day 1: A single dose of BEM will be administered
| Study group | Role | What they receive |
|---|---|---|
| Group 1 -Mild Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) Receives: Drug: Bemnifosbuvir (BEM) |
| Group 2-Moderate Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) Receives: Drug: Bemnifosbuvir (BEM) |
| Group 3 - Healthy Subjects matching mild and moderate impairment groups | Experimental | Drug: single dose Bemnifosbuvir (BEM) Receives: Drug: Bemnifosbuvir (BEM) |
| Group 4 - Severe Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) Receives: Drug: Bemnifosbuvir (BEM) |
| Group 5 - Normal hepatic function matching severe impairment group | Experimental | Drug: single dose Bemnifosbuvir (BEM) Receives: Drug: Bemnifosbuvir (BEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
Measured: Day 1
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
Measured: Day 1
Pharmacokinetics (PK) of BEM 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 posted13 Feb 2023
- Study start30 Jan 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 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
- 39 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
- NCT05724693
- Sponsor's protocol ID
- AT-03A-010
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT05724693
- Acronym / sponsor ID
- AT-03A-010
- Conditions
- Healthy Volunteer, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 13 Feb 2023 (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.
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 -Mild Hepatic Impairment | Experimental | Drug: Bemnifosbuvir (BEM)Drug: single dose Bemnifosbuvir (BEM) |
| Group 2-Moderate Hepatic Impairment | Experimental | Drug: Bemnifosbuvir (BEM)Drug: single dose Bemnifosbuvir (BEM) |
| Group 3 - Healthy Subjects matching mild and moderate impairment groups | Experimental | Drug: Bemnifosbuvir (BEM)Drug: single dose Bemnifosbuvir (BEM) |
| Group 4 - Severe Hepatic Impairment | Experimental | Drug: Bemnifosbuvir (BEM)Drug: single dose Bemnifosbuvir (BEM) |
| Group 5 - Normal hepatic function matching severe impairment group | Experimental | Drug: Bemnifosbuvir (BEM)Drug: single dose Bemnifosbuvir (BEM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 (10 listed)
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, 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 |
|---|---|---|
| Bemnifosbuvir (BEM)Also: AT-527Day 1: A single dose of BEM will be administered | Drug | Group 1 -Mild Hepatic Impairment, Group 2-Moderate Hepatic Impairment, Group 3 - Healthy Subjects matching mild and moderate impairment groups, Group 4 - Severe Hepatic Impairment, Group 5 - Normal hepatic function matching severe impairment group |
Primary outcome
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
Time frame: Day 1
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
Time frame: Day 1
Pharmacokinetics (PK) of BEM 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.
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Screening Protocol
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 Bemnifosbuvir (BEM) in people with Healthy Volunteer and Hepatic Impairment, run by Atea Pharmaceuticals, Inc. at 1 site in United States.
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 10 inclusion and 10 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 United States. 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 BEM 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.