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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Participants will receive S-740792 or placebo. |
|
| Part 2 (Multiple Ascending Dose) | Experimental | Participants will receive S-740792 or placebo, in addition to midazolam. |
|
| Part 3 (Bioavailability) | Experimental | Participants will receive S-740792 as a suspension and as a tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-740792 Suspension | Drug | Participants will receive S-740792 as an oral suspension. |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit, Inc. | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Part 3 will be a 3-sequence, 3-period crossover study.
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Part 3 will be open label.
| Midazolam | Drug | Participants will receive midazolam as a syrup. |
|
| Placebo | Drug | Participants will receive placebo as an oral suspension. |
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| S-740792 Tablet | Drug | Participants will receive S-740792 as an oral tablet. |
|
| 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 |
| D006571 | Heterocyclic Compounds |