Bemnifosbuvir/Ruzasvir for Drug Interaction Study
AS
Overseen ByAtea Study Clinical Trials Administrator
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Atea Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin
Are You a Good Fit for This Trial?
This trial is for healthy volunteers who weigh at least 50 kg with a BMI of 18-30. Participants must use two birth control methods from screening until 90 days after the last dose and agree to follow study rules.Inclusion Criteria
Willing to comply with the study requirements and to provide written informed consent
Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
I weigh at least 50 kg and my BMI is between 18-30.
Exclusion Criteria
Abuse of alcohol or drugs
Use of other investigational drugs within 28 days of dosing
Presence of other clinically significant medical conditions or laboratory abnormalities
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive a single oral dose of Bemnifosbuvir/Ruzasvir and are monitored for drug-drug interactions with Digoxin and Rosuvastatin
1 day
Follow-up
Participants are monitored for safety and pharmacokinetics after treatment
1-2 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Bemnifosbuvir/Ruzasvir
Trial Overview The study tests how Bemnifosbuvir/Ruzasvir (BEM/RZR) affects the body's handling of Digoxin and Rosuvastatin, alone or combined. It compares taking these drugs separately versus together, immediately or delayed by two hours.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZRExperimental Treatment1 Intervention
Group II: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZRExperimental Treatment1 Intervention
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Who Is Running the Clinical Trial?
Atea Pharmaceuticals, Inc.
Lead Sponsor
Trials
29
Recruited
4,600+
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