Ensitrelvir for Drug Interaction Study

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Shionogi

Must not be taking: Oral contraceptives

Disqualifiers: Cardiovascular, Respiratory, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 days

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for healthy adult women with a BMI of ≥18.5 to ≤30.0 kg/m^2 who are not pregnant or breastfeeding, have not used oral contraceptives for at least 28 days, and agree to use effective contraception during the study. Women with significant health issues or history of certain cancers cannot participate.

Inclusion Criteria

Body mass index (BMI) within the range of ≥18.5 to ≤30.0 kilograms (kg)/square meter (m^2) at the screening

I am not pregnant or breastfeeding and meet the fertility criteria.

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

Exclusion Criteria

I don't have major health issues that could affect drug processing or pose risks with the study treatment.

Participants who are otherwise considered ineligible for the study by the investigator for any other reason

I have or am suspected to have had breast, endometrial, or cervical cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined oral contraceptive for 24 days, with ensitrelvir high dose on Day 20 and low dose on Days 21 to 24

24 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ensitrelvir

Trial Overview The study is testing how Ensitrelvir interacts with combined oral contraceptives in the body. It aims to understand if taking Ensitrelvir affects how well the contraceptive works or if it changes Ensitrelvir's effectiveness.

Participant Groups

Group I: Ensitrelvir Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)