Healthy Participants
Conditions
Keywords
First-in-human, S-740792, Midazolam, Bioavailability, Food Effect
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.
Interventions
DRUGS-740792 Suspension
Participants will receive S-740792 as an oral suspension.
DRUGMidazolam
Participants will receive midazolam as a syrup.
DRUGPlacebo
Participants will receive placebo as an oral suspension.
DRUGS-740792 Tablet
Participants will receive S-740792 as an oral tablet.
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 3 will be open label.
Intervention model description
Part 3 will be a 3-sequence, 3-period crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 |
| Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 62 |
| 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) |
| 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 |
Countries
United States
Outcome results
None listed