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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Eurofins Optimed
Gières, France
Oral bioavailability (Fz)
To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Time frame: 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.
Time frame: 72 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 72 hours
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