Healthy Adult Female ParticipantsPhase 1NCT06775730
A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
A Phase 1 study testing Ensitrelvir in people with Healthy Adult Female Participants, run by Shionogi at 1 site in United States.
Trial summary
The purpose of this study is to examine the potential for drug-drug interactions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Female Participants
- What is being tested?
- Ensitrelvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 3 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Phase Clinical Unit Los Angeles
Glendale, California, 91206
About this study
Official title: 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.
- Conditions
- Healthy Adult Female Participants
- Being tested
- Ensitrelvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsitrelvirDrug
Also called S-217622
Ensitrelvir will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ensitrelvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Measured: Predose and up to 24 hours postdose on Days 19, 20, and 24
Cmax of Drospirenone (DRSP)
Measured: Predose and up to 24 hours postdose on Days 19, 20, and 24
Time to Reach Cmax (Tmax) of EE
Measured: Predose and up to 24 hours postdose on Days 19, 20, and 24
Tmax of DRSP
Measured: 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
Measured: Predose and up to 24 hours postdose on Days 19, 20, and 24
AUC0-τ of DRSP
Measured: Predose and up to 24 hours postdose on Days 19, 20, and 24
Secondary outcomes (4)
Number of Participants With Adverse Events (AEs)
Measured: Day 1 up to Day 32
Cmax of Ensitrelvir
Measured: Predose and up to 24 hours postdose on Days 20 and 24
Tmax of Ensitrelvir
Measured: Predose and up to 24 hours postdose on Days 20 and 24
AUC0-τ of Ensitrelvir
Measured: Predose and up to 24 hours postdose on Days 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start30 Dec 2024
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult Female ParticipantsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775730
- Sponsor's protocol ID
- 2403T1219
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shimizu R, Shibata RY, Kubota R, Okuda S, Sonoyama T. Effects of Ensitrelvir on the Pharmacokinetics of Combined Oral Contraceptives (Ethinyl Estradiol/Drospirenone) in Healthy Adult Women: A Phase 1 Fixed-Sequence, Multiple-Dose, Drug-Drug Interaction Study. Clin Drug Investig. 2026 May;46(5):561-570. doi: 10.1007/s40261-026-01541-3. Epub 2026 Mar 31.
PubMed 41915378
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
- ClinicalTrials.gov ID
- NCT06775730
- Acronym / sponsor ID
- 2403T1219
- Conditions
- Healthy Adult Female Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the potential for drug-drug interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensitrelvir | Experimental | Drug: EnsitrelvirParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnsitrelvirAlso: S-217622Ensitrelvir will be administered per schedule specified in the arm description. | Drug | Ensitrelvir |
Primary outcome
Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24
Cmax of Drospirenone (DRSP)
Time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24
Time to Reach Cmax (Tmax) of EE
Time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24
Tmax of DRSP
Time frame: 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
Time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24
AUC0-τ of DRSP
Time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24
4 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Day 1 up to Day 32
Cmax of Ensitrelvir
Time frame: Predose and up to 24 hours postdose on Days 20 and 24
Tmax of Ensitrelvir
Time frame: Predose and up to 24 hours postdose on Days 20 and 24
AUC0-τ of Ensitrelvir
Time frame: Predose and up to 24 hours postdose on Days 20 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41915378Shimizu R, Shibata RY, Kubota R, Okuda S, Sonoyama T. Effects of Ensitrelvir on the Pharmacokinetics of Combined Oral Contraceptives (Ethinyl Estradiol/Drospirenone) in Healthy Adult Women: A Phase 1 Fixed-Sequence, Multiple-Dose, Drug-Drug Interaction Study. Clin Drug Investig. 2026 May;46(5):561-570. doi: 10.1007/s40261-026-01541-3. Epub 2026 Mar 31.
- Individual participant dataSharing planned: No
Related trials for Healthy Adult Female Participants
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ensitrelvir in people with Healthy Adult Female Participants, run by Shionogi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol (EE) (time frame: Predose and up to 24 hours postdose on Days 19, 20, and 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.