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The aim of this study is to investigate different formulations of S-337395.
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Open Label | Experimental | Participants will receive different formulations of S-337395 without food and with food. |
|
| Part B: Double Blind | Experimental | Participants will receive S-337395 or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-337395 | Drug | Administered as an oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Plasma Concentration of S-337395 | Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose) | |
| Part B: Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 29 | |
| Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples) | Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Lenexa | Lenexa | Kansas | 66219 | United States |
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Part A will be open label; Part B will be double blind
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| Placebo | Drug | Administered as an oral suspension. |
|
| Part B: Plasma Concentration of S-337395 | Days 1-12 (Predose, up to 96 hours post dose) |