Actively Recruiting
Effect of Oral Bemnifosbuvir/Ruzasvir on Buprenorphine/Naloxone or Methadone in Stable Opiate Withdrawal Therapy: Phase 1 Open-Label Study
Led by Atea Pharmaceuticals, Inc. · Updated on 2026-04-13
32
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the combination drug Bemnifosbuvir/Ruzasvir (BEM/RZR) interacts with two maintenance therapies, Buprenorphine/Naloxone and Methadone, used for opiate withdrawal. This Phase 1 trial aims to understand the effects of BEM/RZR on the way these drugs are processed in the body, which is important for ensuring safe and effective use together. The study is sponsored by Atea Pharmaceuticals, Inc. Participants will be assigned to one of two groups, either receiving Buprenorphine/Naloxone or Methadone as stable maintenance therapy. Initially, they will take their usual doses alone from Day -5 to Day 5. From Day 6 to Day 12, participants will take their maintenance therapy together with BEM 550mg and RZR 180mg once daily. On Day 13, participants will return to their maintenance therapy without BEM/RZR. The study is open-label and non-randomized. During the study, researchers will measure the levels of buprenorphine, norbuprenorphine, naloxone, and methadone in the participants' blood from Day -5 to Day 13 to see how BEM/RZR affects their pharmacokinetics. Participants must comply with study requirements including contraception and maintaining body weight and BMI limits. Safety and drug interaction effects will be monitored throughout the treatment period. The study is expected to continue until June 2026.
CONDITIONS
Brief Title
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug
- Minimum body weight of 50 kg
- Body mass index (BMI) between 18 and 32 kg/m2
- Willing to comply with study requirements and provide written informed consent
You will not qualify if you...
- Infection with hepatitis B virus, hepatitis C virus, or HIV
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days prior to Day -5
- Use of prescription or systemic over-the-counter medications except assigned maintenance therapy
- Other clinically significant medical conditions or laboratory abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive individualized daily doses of buprenorphine/naloxone or methadone to establish baseline treatment.
Daily dosing with monitoring visits as scheduled
Duration - 13 days
Participants continue individualized daily doses of buprenorphine/naloxone or methadone with added BEM 550mg/RZR 180mg once daily from Day 6 to Day 12, followed by individualized doses of buprenorphine/naloxone or methadone alone on Day 13.
Daily dosing with visits according to protocol
Trial Site Locations
Total: 3 locations
1
Atea Study Site
Hollywood, Florida, United States, 33019
Actively Recruiting
2
Atea Study Site
Overland Park, Kansas, United States, 66212
Actively Recruiting
3
Atea Study Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
Research Team
A
Atea Study Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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