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Last Updated: May 13, 2021

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CLINICAL TRIALS PROFILE FOR GKT137831

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Clinical Trials for GKT137831

Trial ID Title Status Sponsor Phase Summary
NCT02010242 Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria Completed Genkyotex Innovation SAS Phase 2 NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor. The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.
NCT03226067 Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. Recruiting Genkyotex SA Phase 2 The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).
NCT03740217 Bioequivalence Study Not yet recruiting Eurofins Optimed Phase 1 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.
NCT03740217 Bioequivalence Study Not yet recruiting York Bioanalytical Solution Phase 1 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.
NCT03740217 Bioequivalence Study Not yet recruiting Genkyotex SA Phase 1 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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for GKT137831

Condition Name

Condition Name for
Intervention Trials
Phase 1 2
Type 2 Diabetes Mellitus With Diabetic Nephropathy 1
Primary Biliary Cirrhosis 1
Idiopathic Pulmonary Fibrosis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Diabetes Mellitus 1
Idiopathic Interstitial Pneumonias 1
Albuminuria 1
Fibrosis 1
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Clinical Trial Locations for GKT137831

Trials by Country

Trials by Country for
Location Trials
United States 22
Canada 6
United Kingdom 5
Australia 3
Italy 2
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Trials by US State

Trials by US State for
Location Trials
Ohio 2
Illinois 2
Florida 2
California 2
Arizona 2
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Clinical Trial Progress for GKT137831

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 3
Recruiting 1
Completed 1
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Clinical Trial Sponsors for GKT137831

Sponsor Name

Sponsor Name for
Sponsor Trials
Genkyotex SA 3
Genkyotex Innovation SAS 1
University of Alabama at Birmingham 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
Other 1
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