Trial Outcomes & Findings for Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (NCT NCT02330276)
NCT ID: NCT02330276
Last Updated: 2017-04-17
Results Overview
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline and 24 hours
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
10 mg (+)-Epicatechin
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Baseline characteristics by cohort
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 hoursPopulation: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Outcome measures
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Metabolites (AUC nM*hr)
|
105.8 nM*hr
Standard Deviation 122.2
|
132.7 nM*hr
Standard Deviation 148.0
|
162.3 nM*hr
Standard Deviation 209.8
|
|
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
epicatechin-sulfate (AUC nM*hr)
|
291.3 nM*hr
Standard Deviation 119.2
|
1639 nM*hr
Standard Deviation 389.0
|
3031 nM*hr
Standard Deviation 1543
|
|
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
epicatechin-glucuronide (AUC nM*hr)
|
3.375 nM*hr
Standard Deviation 2.488
|
47.18 nM*hr
Standard Deviation 39.41
|
398.3 nM*hr
Standard Deviation 292.7
|
|
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Methyl-epi-sulfate (AUC nM*hr)
|
457.8 nM*hr
Standard Deviation 211.5
|
3190 nM*hr
Standard Deviation 496.6
|
16699 nM*hr
Standard Deviation 7218
|
|
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Total parent compound and metabolites (AUC nM*hr)
|
840.3 nM*hr
Standard Deviation 311.1
|
4996 nM*hr
Standard Deviation 570.0
|
22563 nM*hr
Standard Deviation 10335
|
SECONDARY outcome
Timeframe: Baseline and 24 hoursPopulation: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
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).
Outcome measures
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Change From Baseline in Major Safety Endpoints
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 24 hoursPopulation: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Outcome measures
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
|
368.3 mg/dL*24hr
Standard Deviation 158.5
|
342.6 mg/dL*24hr
Standard Deviation 193.5
|
513.4 mg/dL*24hr
Standard Deviation 185.6
|
SECONDARY outcome
Timeframe: Baseline and 24 hoursPopulation: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Outcome measures
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
|
1192 uU/mL*24 hr
Standard Deviation 488.5
|
707.2 uU/mL*24 hr
Standard Deviation 211.5
|
1334 uU/mL*24 hr
Standard Deviation 666.5
|
SECONDARY outcome
Timeframe: Baseline and 24 hoursPopulation: Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.
Outcome measures
| Measure |
10 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 Participants
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
|
61.74 ng/mL*24hr
Standard Deviation 27.64
|
57.56 ng/mL*24hr
Standard Deviation 28.56
|
64.23 ng/mL*24hr
Standard Deviation 27.11
|
Adverse Events
10 mg (+)-Epicatechin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 mg (+)-Epicatechin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg (+)-Epicatechin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 mg (+)-Epicatechin
n=4 participants at risk
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
(+)-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.
|
30 mg (+)-Epicatechin
n=4 participants at risk
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
(+)-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.
|
100 mg (+)-Epicatechin
n=4 participants at risk
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
(+)-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.
|
|---|---|---|---|
|
Nervous system disorders
Intermittent Headaches
|
0.00%
0/4 • 9 days
|
0.00%
0/4 • 9 days
|
25.0%
1/4 • Number of events 1 • 9 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place