Skip to main content
OpenTrials
Completed

NCT Number: NCT06775730

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Early Phase Clinical Unit Los Angeles

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ensitrelvir

Drug

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

Other names: S-217622

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)

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

  2. Cmax of Drospirenone (DRSP)

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

  3. Time to Reach Cmax (Tmax) of EE

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

  4. Tmax of DRSP

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

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

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

  6. AUC0-τ of DRSP

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

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Day 1 up to Day 32

  2. Cmax of Ensitrelvir

    Time frame: Predose and up to 24 hours postdose on Days 20 and 24

  3. Tmax of Ensitrelvir

    Time frame: Predose and up to 24 hours postdose on Days 20 and 24

  4. AUC0-τ of Ensitrelvir

    Time frame: Predose and up to 24 hours postdose on Days 20 and 24

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.