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

NCT ID: NCT07272889

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EE/LNG

Group Type EXPERIMENTAL

Ethinyl Estradioll/Levonorgestrel (EE/LNG)

Intervention Type DRUG

Treatment-A (EE/LNG): A single 0.03 mg/ 0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be administered in the morning under fasting conditions on Day 1.

BEM/RZR

Group Type EXPERIMENTAL

Bemnifosbuvir/Ruzasvir (BEM/RZR)

Intervention Type DRUG

Treatment-B (BEM/RZR): A 550 mg/180 mg dose of BEM/RZR (2 × 275 mg/90 mg BEM/RZR FDC tablets) will be administered once daily (QD) under fasting conditions on Days 8 to 14.

BEM/RZR + EE/LNG

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment-C (BEM/RZR + EE/LNG): BEM (550 mg)/ RZR (180 mg) as 2 × 275 mg/90 mg BEM/RZR FDC tablets will be administered QD in the morning under fasting conditions on Days 15 to 19. A single 0.03 mg/0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be concomitantly administered with BEM/RZR on the morning of Day 15.

Interventions

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Ethinyl Estradioll/Levonorgestrel (EE/LNG)

Treatment-A (EE/LNG): A single 0.03 mg/ 0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be administered in the morning under fasting conditions on Day 1.

Intervention Type DRUG

Bemnifosbuvir/Ruzasvir (BEM/RZR)

Treatment-B (BEM/RZR): A 550 mg/180 mg dose of BEM/RZR (2 × 275 mg/90 mg BEM/RZR FDC tablets) will be administered once daily (QD) under fasting conditions on Days 8 to 14.

Intervention Type DRUG

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

Treatment-C (BEM/RZR + EE/LNG): BEM (550 mg)/ RZR (180 mg) as 2 × 275 mg/90 mg BEM/RZR FDC tablets will be administered QD in the morning under fasting conditions on Days 15 to 19. A single 0.03 mg/0.15 mg dose of EE/LNG (1 × 0.03 mg/ 0.15 mg tablet) will be concomitantly administered with BEM/RZR on the morning of Day 15.

Intervention Type DRUG

Other Intervention Names

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Portia® 21 BEM (AT-527)/RZR (AT-038) BEM (AT-527)/RZR (AT-038) Portia® 21

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Québec, Montreal, Canada

Site Status

Countries

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Canada

Central Contacts

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Atea Study Clinical Trials Administrator

Role: CONTACT

888-481-1607

Facility Contacts

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Atea Study Clinical Trials Administrator

Role: primary

888-481-1607

Other Identifiers

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AT-01B-012

Identifier Type: -

Identifier Source: org_study_id

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