Testing S-740792 in healthy adults
A Phase 1 Single- and Multiple-ascending-dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-740792 in Healthy Adult Study Participants
This study is testing a new drug called S-740792 in healthy adults to see how safe it is and how it affects the body when taken in different doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Shionogi Inc. Industry-sponsored |
| Locations | 1 site (Daytona Beach, Florida) |
| Trial ID | NCT06724978 on ClinicalTrials.gov |
What this trial studies
This is a two-part interventional study evaluating S-740792 in healthy adult participants. The first part focuses on single-ascending doses to assess safety, tolerability, and pharmacokinetics (PK) of S-740792. The second part examines multiple-ascending doses, looking at the same parameters while also evaluating how S-740792 affects the PK of midazolam. The study aims to gather crucial data on the drug's effects in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a body mass index between 18.5 and 30.0 kg/m².
Not a fit: Patients with significant cardiovascular, respiratory, or other disorders that could affect drug metabolism or pose risks are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide important insights into the safety and pharmacokinetics of S-740792, potentially leading to new treatment options.
How similar studies have performed: While this is a first-in-human study, similar studies of new investigational drugs have shown success in establishing safety and pharmacokinetics.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive). Key Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, 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. * Participants who require medication or other treatment (for example, dietary restrictions or physical therapy). * 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. * Positive test results of the following at screening or within 6 months prior to administration of study intervention: * hepatitis B surface antigen * hepatitis C virus antibody * serological test for syphilis * human immunodeficiency virus antigen/antibody * drug screen * alcohol screen * Participants who have used tobacco or nicotine-containing products (including electronic-cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission or a positive cotinine test at screening or on admission. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Where this trial is running
Daytona Beach, Florida
- Fortrea Clinical Research Unit, Inc. — Daytona Beach, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line
- Email: Shionogiclintrials-admin@shionogi.co.jp
- Phone: 1-800-849-9707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.