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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called S-740792 in healthy adults to assess its safety and tolerability. The trial consists of three parts: the first examines how the body processes different single doses and the effect of food; the second evaluates multiple doses and interactions with another drug, midazolam; the third compares different forms of S-740792 and the impact of food on them. It suits healthy adults not taking any medications, with a body mass index between 18.5 and 30.0. Participants should not have major health issues such as heart or liver problems. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that S-740792 is likely to be safe for humans?

Research has shown that S-740792 is undergoing testing to determine its safety for human use. As an early-stage study, the primary goal is to assess the treatment's safety and tolerability. Researchers closely monitor any side effects and participants' responses after administration.

At this stage, the study focuses on understanding how the body processes different doses of S-740792 and whether it causes any unwanted side effects. This Phase 1 trial marks the first time this treatment is tested in humans. Researchers begin with small doses to ensure safety before administering larger amounts.

Due to the early phase of the research, concrete data on participant reactions is limited. However, Phase 1 trials are designed to prioritize safety. If S-740792 were unsafe, it would not have progressed to this stage. Participating in such a trial helps researchers gather valuable information about the treatment and its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

S-740792 is unique because it is being tested for its ability to be administered both as a suspension and a tablet, which might offer more flexibility and convenience compared to traditional treatments. Researchers are particularly excited about this potential new option as it involves a novel mechanism of action that could provide more rapid or effective results than existing therapies. Additionally, the study includes evaluating the drug with midazolam to assess potential interactions, which could expand its use safely alongside other medications.

What evidence suggests that S-740792 could be effective?

Research on S-740792 remains in the early stages, providing limited information on its efficacy. This trial consists of several parts to evaluate different aspects of S-740792. In Part 1, participants receive either a single ascending dose of S-740792 or a placebo. Part 2 involves multiple ascending doses of S-740792 or placebo, along with midazolam, to study drug interactions. Part 3 assesses the bioavailability of S-740792 by administering it as both a suspension and a tablet. The goal is to determine the safety of S-740792 and its behavior in the body, potentially leading to further studies on its benefits for specific conditions. Currently, no solid evidence shows its effectiveness for any specific health condition. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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)

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06724978

A Study of S-740792 in Healthy Adult Study Participants A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

2. withpower.com withpower.com/trial/s-740792-for-healthy-adults-30f17

S-740792 for Healthy Adults This Phase 1 medical study run by Shionogi is evaluating whether S-740792 will have tolerable side effects & efficacy for patients with Healthy Subjects.

3. app.trialscreen.org app.trialscreen.org/trials/phase-1-s-740792-healthy-adult-participants-trial-nct06724978

A Study of S-740792 in Healthy Adult Study Participants A study to evaluate the safety, tolerability, and pharmacokinetics of an investigational drug called S-740792 in healthy adults · Study Goals · Study Design.

4. ctv.veeva.com ctv.veeva.com/study/a-study-of-s-740792-in-healthy-adult-study-participants

A Study of S-740792 in Healthy Adult Study Participants 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 ...

5. policylab.us policylab.us/clinical-trials/l/florida/daytona-beach/healthy

Healthy Clinical Trials in Daytona Beach, FL - Policy Lab A Study of S-740792 in Healthy Adult Study Participants. NCT06724978. Recruiting. This is a 3-part study of S-740792 in healthy adult participants. Part 1 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06724978/a-study-of-s-740792-in-healthy-adult-study-participants

A Study of S-740792 in Healthy Adult Study Participants 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 ...

7. adisinsight.springer.com adisinsight.springer.com/trials/700378769

A Phase 1 Single- and Multiple-ascending-dose Study to ... 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 ...