S-740792 for Healthy Adults

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Shionogi

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

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

Compensation: Varies

Number of Visits: Unknown

131 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must stop taking their current medications, as the trial excludes those who require medication or other treatments.

What is the purpose of this trial?

This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose and drug-drug interaction) will investigate the safety, tolerability, and PK of S-740792, in addition, the effect of multiple doses of S-740792 on the PK of midazolam. Part 3 will investigate the relative bioavailability of S-740792 tablet compared to S-740792 suspension and the food effect on the PK of the S-740792 tablet.

Eligibility Criteria

This trial is for healthy adults. Specific details about who can join are not provided, but typically participants should have no significant health issues and be within a certain age range.

Inclusion Criteria

Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive)

Exclusion Criteria

Participants who have participated in any other clinical study involving an investigational study intervention or any other type of medical research within 28 days or 5 half-lives of that drug (if known), whichever is longer before signing of the informed consent form for this study or who are currently participating in such a study

I do not have major health issues that could affect drug processing or pose risks with the study treatment.

I need medication or other treatments like diet changes or physical therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive a single ascending dose of S-740792 or placebo to assess safety, tolerability, and pharmacokinetics

4 weeks

Multiple Ascending Dose

Participants receive multiple ascending doses of S-740792 or placebo, and the effect on the pharmacokinetics of midazolam is assessed

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• S-740792

Trial Overview The study tests S-740792 in two parts: one part checks the safety and how the body processes a single dose; another part looks at what happens with repeated doses and how it affects another drug called midazolam.

Participant Groups

Group I: Part 3 (Bioavailability) Experimental Treatment 2 Interventions

Participants will receive S-740792 as a suspension and as a tablet.

Group II: Part 2 (Multiple Ascending Dose) Experimental Treatment 3 Interventions

Participants will receive S-740792 or placebo, in addition to midazolam.

Group III: Part 1 (Single Ascending Dose) Experimental Treatment 2 Interventions

Participants will receive S-740792 or placebo.

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)