NCT07314346 · Atea Pharmaceuticals, Inc.
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
What this study is about
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
View original scientific description
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Interventions
DRUG
Buprenorphine/Naloxone + BEM/RZR
Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg. Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of buprenorphine/naloxone.
DRUG
Methadone +BEM/RZR
Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone.
Primary outcome measures
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Time frame: Day -5 to Day 13
Cmax
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Time frame: Day -5 to Day 13
AUC
Effect of BEM/RZR on PK of methadone
Time frame: Day -5 to Day 13
Cmax
Effect of BEM/RZR on PK of methadone
Time frame: Day -5 to Day 13
AUC
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/ m2.
- Willing to comply with the study requirements and to provide written informed consent.
Exclusion criteria
- Infected with hepatitis B virus, hepatitis C virus, HIV.
- Abuse of alcohol or drugs.
- Use of other investigational drugs within 28 days prior to Day -5.
- Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine/naloxone as assigned maintenance therapy).
- Other clinically significant medical conditions or laboratory abnormalities.
Where
- Hollywood, Florida
- Overland Park, Kansas
- Marlton, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations