Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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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

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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10 mg (+)-epicatechin

4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally

Group Type EXPERIMENTAL

(+)-Epicatechin

Intervention Type DRUG

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.

30 mg (+)-epicatechin

4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally

Group Type EXPERIMENTAL

(+)-Epicatechin

Intervention Type DRUG

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.

100 mg (+)-epicatechin

4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Group Type EXPERIMENTAL

(+)-Epicatechin

Intervention Type DRUG

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.

Interventions

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(+)-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.

Intervention Type DRUG

Other Intervention Names

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Epicatechin

Eligibility Criteria

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Inclusion Criteria

* Healthy or pre-diabetic based on medical history
* Male or female
* Must be 21 to 75 years of age (inclusive)
* Able to give informed consent to the procedures
* If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
* If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
* Medication use stable for 4 weeks
* Body Mass Index (BMI) \> 27 kg/m\^2
* Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

Exclusion Criteria

* Type 2 diabetes
* Pregnancy
* Younger than 21 or older than 75 years of age
* Clinically significant abnormalities in liver or kidney function (\>3x ULN), determined in the last 6 months by a certified clinical laboratory
* Recent MI or stroke (within 6 months of screening)
* Blood pressure (BP) \>160 mmHg Systolic and \>100 mmHg Diastolic
* Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
* Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes