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| Name | Class |
|---|---|
| Eurofins Optimed | INDUSTRY |
| York Bioanalytical Solution | INDUSTRY |
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The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.
This will be a randomized three-way open cross-over study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Other | Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions. |
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| Treatment B: | Other | Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions. |
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| Treatment C | Other | Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GKT137831 | Drug | oral bioavailable small molecule that selectively inhibit NOX1 and NOX4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Oral bioavailability (Fz) | To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects. | 72 hours |
| Food effect on Oral bioavailability (Fz) | To assess the impact of concomitant food intake on the relative bioavailability of GKT137831 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | To compare the safety and tolerability of single oral dose administration of 400 mg GKT137831 formulated in capsules or in tablets, and to evaluate the potential impact of concomitant food intake on the safety and tolerability of single oral dose administration of 400 mg GKT137831 tablet in healthy adult male subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves DONAZZOLO, MD | Eurofins Optimed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | 38610 | France |
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| ID | Term |
|---|---|
| C576694 | setanaxib |
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Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).
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| 7 days |
| Oral bioavailability of GKT138184 | To compare the relative oral bioavailability GKT138184 after oral administration of GKT137831 formulated in capsules or in tablets in healthy male subjects. | 72 hours |
| Food effect on oral bioavailability of GKT138184 | To assess the impact of concomitant food intake on the relative bioavailability of GKT138184 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects. | 72 hours |