Healthy Volunteer StudyPhase 1AT-527NCT05731843
Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
A Phase 1 study testing Cohort 1 BEM + Ruzasvir and Cohort 2 Ruzasvir + BEM in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Cohort 1 BEM + Ruzasvir and Cohort 2 Ruzasvir + BEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2023to 15 Mar 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- 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.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2.
- Willing to comply with the study requirements and to provide written informed consent.
Who cannot join
- Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
- Abuse of alcohol or drugs.
- Use of other investigational drugs within 28 days of dosing.
- Concomitant use of prescription medications, or systemic over-the-counter medications.
- Other clinically significant medical conditions or laboratory abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
- Conditions
- Healthy Volunteer Study
- Being tested
- Cohort 1 BEM + Ruzasvir, Cohort 2 Ruzasvir + BEM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 BEM + RuzasvirDrug
Also called AT-527
Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions
Cohort 2 Ruzasvir + BEMDrug
Also called AT-527
Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| BEM vs BEM + Ruzasvir n=16 | Experimental | Not described Receives: Drug: Cohort 1 BEM + Ruzasvir |
| Ruzasvir vs Ruzasvir + BEM n=16 | Experimental | Not described Receives: Drug: Cohort 2 Ruzasvir + 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) and Area under the plasma concentration-time curve (AUC)
Measured: Days 6, 12, 18
Pharmacokinetics (PK) of Ruzasvir
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Measured: Days 6, 12, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start30 Jan 2023
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- 32 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
- NCT05731843
- Sponsor's protocol ID
- AT-01B-003
- Acronym
- AT-527
- Status last verified
- May 2023
- First submitted
- 9 Feb 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05731843
- Acronym / sponsor ID
- AT-527 / AT-01B-003
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 16 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.
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEM vs BEM + Ruzasvir n=16 | Experimental | Drug: Cohort 1 BEM + Ruzasvir |
| Ruzasvir vs Ruzasvir + BEM n=16 | Experimental | Drug: Cohort 2 Ruzasvir + BEM |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2.
- Willing to comply with the study requirements and to provide written informed consent.
Key exclusion criteria (5 listed)
- Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
- Abuse of alcohol or drugs.
- Use of other investigational drugs within 28 days of dosing.
- Concomitant use of prescription medications, or systemic over-the-counter medications.
- 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 |
|---|---|---|
| Cohort 1 BEM + RuzasvirAlso: AT-527Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions | Drug | BEM vs BEM + Ruzasvir n=16 |
| Cohort 2 Ruzasvir + BEMAlso: AT-527Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions | Drug | Ruzasvir vs Ruzasvir + BEM n=16 |
Primary outcome
Pharmacokinetics (PK) of BEM
Time frame: Days 6, 12, 18
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of Ruzasvir
Time frame: Days 6, 12, 18
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
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 1 Jun 2023.
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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 Cohort 1 BEM + Ruzasvir and Cohort 2 Ruzasvir + BEM in people with Healthy Volunteer Study, 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 3 inclusion and 5 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 1 Jun 2023. 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 BEM (time frame: Days 6, 12, 18). The study lists 2 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 1 Jun 2023.