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Antiviral Combination

BEM/RZR vs BEM/RZR + BIK vs BIK for Healthy Volunteer Study

Phase 1

Waitlist Available

Research Sponsored by Atea Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 7-10, day 12, days 14-17, days 21-24.

Awards & highlights

Study Summary

This trial will investigate how two different drugs, Biktarvy and Bemnifosbuvir/Ruzasvir, interact with each other when taken together.

Who is the study for?

This trial is for healthy adults who agree to use two forms of birth control, weigh at least 50 kg with a BMI of 18-30, and are willing to follow study rules. People with hepatitis B/C, HIV, SARS-CoV-2 or drug/alcohol abuse can't join. Also excluded are those on other meds or trials within the last month.Check my eligibility

What is being tested?

The study tests how Biktarvy interacts with Bemnifosbuvir/Ruzasvir in the body. Participants take these drugs in different orders and combinations over a period of up to 24 days to see if there are any changes in how they work when taken together.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions typical for antiviral medications such as headache, nausea, fatigue, and possible interactions that could affect drug effectiveness or cause unexpected health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 7-10, day 12, days 14-17, days 21-24.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 7-10, day 12, days 14-17, days 21-24.

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7-10, day 12, days 14-17, days 21-24. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).

To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)

Trial Design

2Treatment groups

Experimental Treatment

Group I: BIK vs BEM/RZR + BIK vs BEM/RZRExperimental Treatment1 Intervention

n=14

Group II: BEM/RZR vs BEM/RZR + BIK vs BIKExperimental Treatment1 Intervention

n=14

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Atea Pharmaceuticals, Inc.Lead Sponsor

27 Previous Clinical Trials

3,789 Total Patients Enrolled

12 Trials studying Healthy Volunteer Study

445 Patients Enrolled for Healthy Volunteer Study

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 and above eligible to participate in this medical research study?

"The study is seeking individuals above 18 years and under the age of 55 to participate."

Answered by AI

What are the specific criteria for eligibility to partake in this study?

"Candidates eligible for participation in this trial must be healthy volunteers aged between 18 and 55. The study aims to recruit approximately 28 individuals."

Answered by AI

Is the current clinical trial open for patient enrollment at this time?

"As per clinicaltrials.gov, the present trial is not actively seeking volunteers. Originally shared on 4/15/2024 and last revised on 4/4/2024, it has since concluded patient recruitment. However, one alternative study is currently accepting participants into their research program."

Answered by AI

Has the combination therapy of BEM/RZR compared to BEM/RZR + BIK been officially sanctioned by the FDA?

"According to our evaluation at Power, the safety of BEM/RZR vs BEM/RZR + BIK vs BIK is rated as 1 on a scale from 1 to 3. This rating reflects that this trial is in Phase 1 with minimal data available to support both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

2024. "Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06356194.