A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants

NCT ID: NCT06775730

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-04-03

Brief Summary

The purpose of this study is to examine the potential for drug-drug interactions.

Conditions

Healthy Adult Female Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ensitrelvir

Participants will receive multiple oral doses of a combined oral contraceptive (COC) (EE and DRSP) once daily for 24 days (Days 1 to 24) (in the fasted state on Days 18 to 24) in the morning. Participants will also receive ensitrelvir high dose on Day 20 and multiple oral doses of ensitrelvir low dose once daily on Days 21 to 24 in the fasted state.

Group Type: EXPERIMENTAL

Ensitrelvir

Intervention Type: DRUG

Ensitrelvir will be administered per schedule specified in the arm description.

Interventions

Ensitrelvir

Ensitrelvir will be administered per schedule specified in the arm description.

Intervention Type: DRUG

Other Intervention Names

S-217622

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) within the range of ≥18.5 to ≤30.0 kilograms (kg)/square meter (m^2) at the screening.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and either of the following conditions applies:

• Is a woman of childbearing potential (WOCBP), having not received any oral contraceptives for at least 28 days prior to the first dose of study intervention, and using a contraceptive method that is highly effective during the treatment period and for at least 14 days after the last dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.

Exclusion Criteria

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Presence (suspected) or history of having breast cancer, endometrial cancer, or cervical cancer.
• Presence of unexplained genital bleeding.
• Participants who have taken injectable or implantable contraceptives, hormonal intrauterine devices, intrauterine hormone-releasing system within 12 months prior to the first dose of study intervention or hormonal contraceptives (intravaginal or transdermal) for 3 months prior to the first dose of study intervention.
• Participants who are otherwise considered ineligible for the study by the investigator for any other reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Early Phase Clinical Unit Los Angeles

Glendale, California, United States

Countries

United States

Other Identifiers

2403T1219

Identifier Type: -

Identifier Source: org_study_id