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Antiviral

FDC Fed for Healthy Volunteer Study

Phase 1
Recruiting
Research Sponsored by Atea Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 7, day 13
Awards & highlights

Study Summary

This trial is going to test how well a combination of two drugs, Bemnifosbuvir and Ruzasvir, work in the body and if they are affected by food.

Who is the study for?
This trial is for healthy individuals who want to help test a new combination tablet of two drugs, Bemnifosbuvir and Ruzasvir. The study will look at how the body processes these drugs when taken together under different conditions like with or without food.Check my eligibility
What is being tested?
The trial is testing how a fixed-dose combo tablet of Bemnifosbuvir (BEM) and Ruzasvir (RZR) behaves in the body when taken by healthy people. It compares taking it on an empty stomach versus with food to see if there's any difference in absorption.See study design
What are the potential side effects?
Since this study involves healthy volunteers, side effects are closely monitored but may include digestive discomfort, headache, or allergic reactions. These are typical risks associated with taking new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg and my BMI is between 18 and 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 7, day 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 7, day 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC)
Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax)
Pharmacokinetics (PK) of FDC compared to reference:(AUC)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Reference FastingExperimental Treatment1 Intervention
Day 1, Day 7, Day 13
Group II: FDC FedExperimental Treatment1 Intervention
Day 1, Day 7, Day 13
Group III: FDC FastingExperimental Treatment1 Intervention
Day 1, Day 7, Day 13

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
4,012 Total Patients Enrolled
12 Trials studying Healthy Volunteer Study
453 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 eligible patients able to enroll in this ongoing trial at the present time?

"Indeed, the information provided on clinicaltrials.gov affirms that this particular clinical trial is presently seeking participants. It was originally posted on December 14th, 2023 and recently updated on January 11th, 2024. The study aims to recruit a total of 20 individuals from one designated site."

Answered by AI

Does this clinical trial have an age limit that excludes individuals older than 30 years?

"This medical investigation is open to individuals who have reached the age of consent but are under 65 years old."

Answered by AI

Has the FDA given its approval for Reference Fasting as a valid medical procedure?

"Since this is a Phase 1 trial, there is limited data available to support the safety and efficacy of Reference Fasting. Hence, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, the details provided on clinicaltrials.gov highlight that this ongoing clinical trial is actively seeking potential candidates. It was initially posted on December 14th, 2023 and most recently updated on January 11th, 2024. The study aims to enroll a total of 20 participants from a single location."

Answered by AI

Which individuals are eligible to participate in this clinical research study?

"To be eligible for participation in this clinical trial, candidates must meet the criteria of being a healthy volunteer between 18 and 65 years old. The study aims to recruit approximately 20 patients."

Answered by AI

Who else is applying?

What site did they apply to?
Atea Study Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

have done other trials in my area.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir
2023. "Pharmacokinetics of Fixed-Dose Combination Tablet of Bemnifosbuvir and Ruzasvir". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06204679.
~13 spots leftby Apr 2025
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