Eurofins Optimed
Gières, 38610, France
NCT Number: NCT03740217
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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Notify Me18 year–60 year
Male
Interventional
Phase 1
Gières, 38610, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Other names: NOX1/4 inhibitor
Time frame: 72 hours
To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Time frame: 72 hours
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: 7 days
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: 72 hours
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
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.
Calliditas Therapeutics AB
Industry
Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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