Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
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.
VA San Diego Healthcare System
San Diego, California, United States
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Time frame: Baseline and 24 hours
Change From Baseline in Major Safety Endpoints
Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (\>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (\>1.5 ULN).
Time frame: Baseline and 24 hours
Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
Time frame: Baseline and 24 hours
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Time frame: Baseline and 24 hours
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
Time frame: Baseline and 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.