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

NCT06775730 | Completed Phase 1 FDA Drug

• 1 other identifier: 2403T1219
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Female Participants

Outcome Measures

Primary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)

  Predose and up to 24 hours postdose on Days 19, 20, and 24

• Cmax of Drospirenone (DRSP)

  Predose and up to 24 hours postdose on Days 19, 20, and 24

• Time to Reach Cmax (Tmax) of EE

  Predose and up to 24 hours postdose on Days 19, 20, and 24

• Tmax of DRSP

  Predose and up to 24 hours postdose on Days 19, 20, and 24

• Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-τ) of EE

  Predose and up to 24 hours postdose on Days 19, 20, and 24

• AUC0-τ of DRSP

  Predose and up to 24 hours postdose on Days 19, 20, and 24

Secondary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  Day 1 up to Day 32

• Cmax of Ensitrelvir

  Predose and up to 24 hours postdose on Days 20 and 24

• Tmax of Ensitrelvir

  Predose and up to 24 hours postdose on Days 20 and 24

• AUC0-τ of Ensitrelvir

  Predose and up to 24 hours postdose on Days 20 and 24

Study Arms (1)

Ensitrelvir

EXPERIMENTAL

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.

Drug: Ensitrelvir

Interventions

Ensitrelvir DRUG

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

Also known as: S-217622

Ensitrelvir

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Early Phase Clinical Unit Los Angeles

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

ensitrelvir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: December 30, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)