Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)

Atea Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Bemnifosbuvir/Ruzasvir (BEM/RZR); Drug: Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG); Drug: Ethinyl Estradioll/Levonorgestrel (EE/LNG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07272889

AT-01B-012

Details and patient eligibility

About

Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy post-menopausal or hormonally sterile female
• Minimum body weight of 50 kg and body mass index (BMI) of 18.0-30 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 or SARS-CoV-2.
• Abuse of alcohol or drugs.
• Use of other investigational drugs within 28 days of dosing.
• Concomitant use of prescription medications, or systemic over-the-counter medications.
• 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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24 participants in 3 patient groups

EE/LNG

Experimental group

Treatment:

Drug: Ethinyl Estradioll/Levonorgestrel (EE/LNG)

BEM/RZR

Experimental group

Treatment:

Drug: Bemnifosbuvir/Ruzasvir (BEM/RZR)

BEM/RZR + EE/LNG

Experimental group

Treatment:

Drug: Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG)