Clinical trial NCT06775730: A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
Official title: A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Female Participants
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
measure: Cmax of Drospirenone (DRSP)
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
measure: Time to Reach Cmax (Tmax) of EE
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
measure: Tmax of DRSP
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
measure: Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-τ) of EE
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
measure: AUC0-τ of DRSP
timeFrame: Predose and up to 24 hours postdose on Days 19, 20, and 24
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Day 1 up to Day 32
measure: Cmax of Ensitrelvir
timeFrame: Predose and up to 24 hours postdose on Days 20 and 24
measure: Tmax of Ensitrelvir
timeFrame: Predose and up to 24 hours postdose on Days 20 and 24
measure: AUC0-τ of Ensitrelvir
timeFrame: Predose and up to 24 hours postdose on Days 20 and 24
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Early Phase Clinical Unit Los Angeles
state: California
Study officials:
References: