BEM vs BEM + Ruzasvir n=16 for Healthy Volunteer Study

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atea Study Site, Québec, CanadaHealthy Volunteer StudyCohort 2 Ruzasvir + BEM - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study Summary

This trial tested how two drugs, Ruzasvir & Bemnifosbuvir, interact when taken together to treat Hepatitis C.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Days 6, 12, 18

Days 6, 12, 18
Pharmacokinetics (PK) of BEM
Pharmacokinetics (PK) of Ruzasvir

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

BEM vs BEM + Ruzasvir n=16
1 of 2
Ruzasvir vs Ruzasvir + BEM n=16
1 of 2

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: BEM vs BEM + Ruzasvir n=16 · No Placebo Group · Phase 1

BEM vs BEM + Ruzasvir n=16
Drug
Experimental Group · 1 Intervention: Cohort 1 BEM + Ruzasvir · Intervention Types: Drug
Ruzasvir vs Ruzasvir + BEM n=16
Drug
Experimental Group · 1 Intervention: Cohort 2 Ruzasvir + BEM · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 6, 12, 18

Who is running the clinical trial?

Atea Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
3,830 Total Patients Enrolled
8 Trials studying Healthy Volunteer Study
344 Patients Enrolled for Healthy Volunteer Study

Eligibility Criteria

Age 18 - 55 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must agree to use two types of birth control during the screening process and for 90 days after taking the final dose of medication.
You weigh at least 50 kg and have a BMI between 18-29 kg/m2.
You are willing to abide by the study criteria and provide written permission.

Frequently Asked Questions

Is this research accommodating individuals over 45 years of age?

"Individuals aged between 18 and 55 can join this clinical trial." - Anonymous Online Contributor

Unverified Answer

What are the relative safety implications of BEM alone versus a combination treatment with BEM and Ruzasvir among 16 patients?

"The safety of BEM combined with Ruzasvir, based on the small sample size of 16 patients, has been deemed a 1 due to its Phase 1 clinical trial status. This implies that there is only limited data available supporting both safety and efficacy." - Anonymous Online Contributor

Unverified Answer

Is this trial currently open for enrollment?

"Affirmative. According to clinicaltrials.gov, this medical trial is presently searching for volunteers and was first posted on January 30th 2023 with the latest update occurring on February 9th of that same year. 32 individuals are required from 1 trial site in total." - Anonymous Online Contributor

Unverified Answer

How many participants are actively involved in this clinical investigation?

"Affirmative. Clinicaltrials.gov records point to this medical study still recruiting patients, which was initially posted on January 30th 2023 and last updated February 9th of the same year. There are 32 positions available at a single site for prospective participants." - Anonymous Online Contributor

Unverified Answer

Are there any particular demographics that would make someone a favorable candidate for this clinical trial?

"This clinical trial requires 32 volunteers aged 18-55 with a healthy body weight of 50 kilograms and BMI between 18-29 kg/m2. In addition, participants must agree to use two forms of contraception from Screening through 90 days after taking the last dose of medication. Furthermore, all candidates must be willing to comply with the study's requirements and provide written informed consent." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.