Healthy ParticipantsPhase 1NCT06724978
A Study of S-740792 in Healthy Adult Study Participants
A Phase 1 study testing S-740792 Suspension, Midazolam and S-740792 Tablet in people with Healthy Participants, run by Shionogi at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- S-740792 Suspension, Midazolam and S-740792 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 24 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit, Inc.
Daytona Beach, Florida, 32117
About this study
Official title: 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 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.
- Conditions
- Healthy Participants
- Being tested
- S-740792 Suspension, Midazolam, Placebo, S-740792 Tablet
- Keywords
- First-in-human, S-740792, Midazolam, Bioavailability, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-740792 SuspensionDrug
Participants will receive S-740792 as an oral suspension.
MidazolamDrug
Participants will receive midazolam as a syrup.
PlaceboDrug
Participants will receive placebo as an oral suspension.
S-740792 TabletDrug
Participants will receive S-740792 as an oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Participants will receive S-740792 or placebo. Receives: Drug: S-740792 Suspension; Drug: Placebo |
| Part 2 (Multiple Ascending Dose) | Experimental | Participants will receive S-740792 or placebo, in addition to midazolam. Receives: Drug: S-740792 Suspension; Drug: Midazolam; Drug: Placebo |
| Part 3 (Bioavailability) | Experimental | Participants will receive S-740792 as a suspension and as a tablet. Receives: Drug: S-740792 Suspension; Drug: S-740792 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 28
Part 3: Plasma Concentration of S-740792
Measured: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792
Measured: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Secondary outcomes (7)
Parts 1 and 2: Plasma Concentration of S-740792
Measured: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792
Measured: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Part 1: Plasma Concentration of S-740792 After a High-fat Meal
Measured: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 1: Tmax of S-740792 After a High-fat Meal
Measured: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 2: Plasma Concentration of Midazolam After Administration of S-740792
Measured: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 2: Tmax of Midazolam After Administration of S-740792
Measured: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start21 Nov 2024
- Primary completion10 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 3 will be a 3-sequence, 3-period crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724978
- Sponsor's protocol ID
- 2318VA711
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single- and Multiple-ascending-dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-740792 in Healthy Adult Study Participants
- ClinicalTrials.gov ID
- NCT06724978
- Acronym / sponsor ID
- 2318VA711
- Conditions
- Healthy Participants
- Keywords
- First-in-human, S-740792, Midazolam, Bioavailability, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part 3 will be a 3-sequence, 3-period crossover study.
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Drug: S-740792 Suspension, Drug: PlaceboParticipants will receive S-740792 or placebo. |
| Part 2 (Multiple Ascending Dose) | Experimental | Drug: S-740792 Suspension, Drug: Midazolam, Drug: PlaceboParticipants will receive S-740792 or placebo, in addition to midazolam. |
| Part 3 (Bioavailability) | Experimental | Drug: S-740792 Suspension, Drug: S-740792 TabletParticipants will receive S-740792 as a suspension and as a tablet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-740792 SuspensionParticipants will receive S-740792 as an oral suspension. | Drug | Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose), Part 3 (Bioavailability) |
| MidazolamParticipants will receive midazolam as a syrup. | Drug | Part 2 (Multiple Ascending Dose) |
| PlaceboParticipants will receive placebo as an oral suspension. | Drug | Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) |
| S-740792 TabletParticipants will receive S-740792 as an oral tablet. | Drug | Part 3 (Bioavailability) |
Primary outcome
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 28
Part 3: Plasma Concentration of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
7 secondary outcomes
Parts 1 and 2: Plasma Concentration of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Part 1: Plasma Concentration of S-740792 After a High-fat Meal
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 1: Tmax of S-740792 After a High-fat Meal
Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 2: Plasma Concentration of Midazolam After Administration of S-740792
Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 2: Tmax of Midazolam After Administration of S-740792
Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 62
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-740792 Suspension, Midazolam and S-740792 Tablet in people with Healthy Participants, run by Shionogi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events (time frame: Day 1 through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.