Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone

Atea Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Methadone +BEM/RZR; Drug: Buprenorphine/Naloxone + BEM/RZR

Study type: Interventional

Funder types: Industry

Identifiers

NCT07314346

AT-01B-013

Details and patient eligibility

About

Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

(n=16) buprenorphine/naloxone + BEM/RZR

Experimental group

Treatment:

Drug: Buprenorphine/Naloxone + BEM/RZR

(n=16) methadone + BEM/RZR

Experimental group

Treatment:

Drug: Methadone +BEM/RZR