S-740792 for Healthy Adults

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Shionogi

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a 2-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose) 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.

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.

Research Team

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.

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Trial 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 (Other)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Part 2 (Multiple Ascending Dose)Experimental Treatment3 Interventions

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

Group II: Part 1 (Single Ascending Dose)Experimental Treatment2 Interventions

Participants will receive S-740792 or placebo.