NCT07272889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 4, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2026

Completed
Last Updated

April 13, 2026

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 19, 2025

Last Update Submit

April 8, 2026

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

  • PK of EE/LNG (Cmax)

    Day 1,15

  • PK of EE/LNG (AUC)

    Day 1,15

Study Arms (3)

EE/LNG

EXPERIMENTAL
Drug: Ethinyl Estradioll/Levonorgestrel (EE/LNG)

BEM/RZR

EXPERIMENTAL
Drug: Bemnifosbuvir/Ruzasvir (BEM/RZR)

BEM/RZR + EE/LNG

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

Interventions

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

Also known as: BEM (AT-527)/RZR (AT-038), Portia® 21
BEM/RZR + EE/LNG
Bemnifosbuvir/Ruzasvir (BEM/RZR)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.

Also known as: BEM (AT-527)/RZR (AT-038)
BEM/RZR
Ethinyl Estradioll/Levonorgestrel (EE/LNG)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.

Also known as: Portia® 21
EE/LNG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Québec, Montreal, Canada

Location

MeSH Terms

Interventions

Levonorgestrelruzasvir

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

December 4, 2025

Primary Completion

February 17, 2026

Study Completion

February 17, 2026

Last Updated

April 13, 2026

Record last verified: 2025-11

Locations

CA(1)