Healthy Adult Female Participants
Conditions
Brief summary
The purpose of this study is to examine the potential for drug-drug interactions.
Interventions
DRUGEnsitrelvir
Ensitrelvir will be administered per schedule specified in the arm description.
Sponsors
Shionogi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-τ of DRSP | 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 |
| Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE) | Predose and up to 24 hours postdose on Days 19, 20, and 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants With Adverse Events (AEs) | Day 1 up to Day 32 |
Countries
United States
Outcome results
None listed