NCT02330276

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Detailed description

This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DRUG	(+)-Epicatechin	The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-01-01
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States