NCT03740217

Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Calliditas Therapeutics AB · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Phase 1

Interventions

Type	Name	Description
DRUG	GKT137831	oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Timeline

• Start date: 2018-12-19
• Primary completion: 2019-02-06
• Completion: 2019-02-06
• First posted: 2018-11-14
• Last updated: 2022-06-30

Locations

1 site across 1 country: France