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

A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Female Participants
• Intervention / Treatment: Drug: Ensitrelvir

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Early Phase Clinical Unit Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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.

Key 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.

NOTE: Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ensitrelvir; Ensitrelvir will be administered per schedule specified in the arm description.; Other Names: S-217622

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2403T1219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No