Healthy Volunteer StudyPhase 1NCT05905484
Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects
A Phase 1 study testing Bemnifosbuvir (BEM) and Moxifloxacin in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects 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?
- Bemnifosbuvir (BEM) and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2023to 31 May 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
- Females must have a negative pregnancy test at Screening and prior to dosing
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization in Healthy Adult Subjects
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects
- Conditions
- Healthy Volunteer Study
- Being tested
- Bemnifosbuvir (BEM), Placebo, Moxifloxacin
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
A single dose of BEM will be administered.
PlaceboDrug
A single dose of matching placebo will be administered.
MoxifloxacinDrug
A single dose of Moxifloxacin will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Bemnifosbuvir (BEM) therapeutic dose | Experimental | oral tablets Receives: Drug: Bemnifosbuvir (BEM) |
| Bemnifosbuvir (BEM) supratherapeutic dose | Experimental | oral tablets Receives: Drug: Bemnifosbuvir (BEM) |
| Placebo | Placebo comparator | oral tablets Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | oral tablet Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).
C-QTc analysis
Measured: 24 hours prior to dosing thru 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start25 Apr 2023
- Primary completion31 May 2023
- Study completion31 May 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 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
- NCT05905484
- Sponsor's protocol ID
- AT-03A-008
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05905484
- Acronym / sponsor ID
- AT-03A-008
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Jun 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.
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bemnifosbuvir (BEM) therapeutic dose | Experimental | Drug: Bemnifosbuvir (BEM)oral tablets |
| Bemnifosbuvir (BEM) supratherapeutic dose | Experimental | Drug: Bemnifosbuvir (BEM)oral tablets |
| Placebo | Placebo comparator | Drug: Placebooral tablets |
| Moxifloxacin | Active comparator | Drug: Moxifloxacinoral tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- 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)
- 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-527A single dose of BEM will be administered. | Drug | Bemnifosbuvir (BEM) supratherapeutic dose, Bemnifosbuvir (BEM) therapeutic dose |
| PlaceboA single dose of matching placebo will be administered. | Drug | Placebo |
| MoxifloxacinA single dose of Moxifloxacin will be administered. | Drug | Moxifloxacin |
Primary outcome
Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).
Time frame: 24 hours prior to dosing thru 48 hours post dose
C-QTc analysis
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 15 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 Bemnifosbuvir (BEM) and Moxifloxacin 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 4 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 15 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. Some participants in this study may receive a placebo. 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?
Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc). (time frame: 24 hours prior to dosing thru 48 hours post dose). 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 15 Jun 2023.