Healthy Volunteer StudyPhase 1NCT06204679

Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir

A Phase 1 study testing Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions, Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions and Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions, Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions and Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2023to 25 Aug 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 65 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.
Minimum body weight of 50 kg and body mass index (BMI) of 18-30 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.

United States1 site

Atea Study Site
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects

This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects

Conditions: Healthy Volunteer Study
Being tested: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions, Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions, Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditionsDrug
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditionsDrug
A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditionsDrug
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations

Study groups in NCT06204679
Study group	Role	What they receive
FDC Fasting	Experimental	Day 1, Day 7, Day 13 Receives: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions
FDC Fed	Experimental	Day 1, Day 7, Day 13 Receives: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions
Reference Fasting	Experimental	Day 1, Day 7, Day 13 Receives: Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 7, Day 13
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
Area under the plasma concentration-time curve (AUC)
Measured: Day 1, Day 7, Day 13
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 7, Day 13
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
Area under the plasma concentration-time curve (AUC)
Measured: Day 1, Day 7, Day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202325 Aug 2024

First posted12 Jan 2024
Study start14 Dec 2023
Primary completion25 Aug 2024
Study completion25 Aug 2024

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: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06204679
Sponsor's protocol ID: AT-01B-005
Status last verified: Sep 2024
First submitted: 2 Jan 2024
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteer Study trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label Study to Assess Comparative Bioavailability and Effect of Food on a Prototype Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir Versus Individual Dosage Forms Taken Concomitantly in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06204679
Acronym / sponsor ID: AT-01B-005
Conditions: Healthy Volunteer Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 14 Dec 2023 (actual)
Primary completion: 25 Aug 2024 (actual)
Study completion: 25 Aug 2024 (actual)
First posted: 12 Jan 2024 (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 comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
FDC Fasting	Experimental	Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditionsDay 1, Day 7, Day 13
FDC Fed	Experimental	Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditionsDay 1, Day 7, Day 13
Reference Fasting	Experimental	Drug: Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditionsDay 1, Day 7, Day 13

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older 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 18-30 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
Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditionsA Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)	Drug	FDC Fasting
Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditionsA Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR)	Drug	FDC Fed
Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditionsBemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations	Drug	Reference Fasting

Primary outcome

Pharmacokinetics (PK) of FDC compared to reference:(Cmax)
Time frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
Time frame: Day 1, Day 7, Day 13
Area under the plasma concentration-time curve (AUC)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Time frame: Day 1, Day 7, Day 13
Maximum plasma concentration (Cmax)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
Time frame: Day 1, Day 7, Day 13
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 19 Sep 2024.

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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?

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 19 Sep 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 FDC compared to reference:(Cmax) (time frame: Day 1, Day 7, Day 13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06204679.

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 19 Sep 2024.