A Study of S-740792 in Healthy Adult Study Participants
Phase 1
Recruiting
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT06724978
- Lead Sponsor
- Shionogi
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 131
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 (Single Ascending Dose) S-740792 Suspension Participants will receive S-740792 or placebo. Part 1 (Single Ascending Dose) Placebo Participants will receive S-740792 or placebo. Part 2 (Multiple Ascending Dose) S-740792 Suspension Participants will receive S-740792 or placebo, in addition to midazolam. Part 2 (Multiple Ascending Dose) Midazolam Participants will receive S-740792 or placebo, in addition to midazolam. Part 2 (Multiple Ascending Dose) Placebo Participants will receive S-740792 or placebo, in addition to midazolam. Part 3 (Bioavailability) S-740792 Suspension Participants will receive S-740792 as a suspension and as a tablet. Part 3 (Bioavailability) S-740792 Tablet Participants will receive S-740792 as a suspension and as a tablet.
- Primary Outcome Measures
Name Time Method Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events Day 1 through Day 28 Part 3: Plasma Concentration of S-740792 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 Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Plasma Concentration of S-740792 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 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 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 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 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 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 Day 1 through Day 62
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular targets does S-740792 modulate to influence CYP3A4-mediated midazolam pharmacokinetics in NCT06724978?
How does S-740792's safety profile compare to other P-gp inhibitors in Phase 1 trials of healthy volunteers?
Which biomarkers correlate with inter-individual variability in S-740792 pharmacokinetics observed in NCT06724978?
What are the mechanisms underlying S-740792-induced drug-drug interactions with CYP substrates like midazolam?
How does Shionogi's S-740792 compare to elacridar in modulating ABCB1 transporter activity in early-phase trials?
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit, Inc.
🇺🇸Daytona Beach, Florida, United States
Fortrea Clinical Research Unit, Inc.🇺🇸Daytona Beach, Florida, United States