Trial · Interventional

CompletedPhase 1Results postedRegistry data

The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels

NCTNCT01251315Other id10 - 04 - 2268 - 01

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 24 participants (actual)
Sponsor: Charles Drew University of Medicine and Science · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2010
Primary completion: Jun 2011
Completion: Jun 2011
First posted: 1 Dec 2010 (estimated)
Last update posted: 14 Apr 2014 (estimated)
Conditions: Oxidative Stress

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph 1
The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
NCT01251315
Dec 2010 to Jun 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Glutathione is a powerful protective substance found within every cell in the body. It has been shown that glutathione levels go down as a person gets older, which makes a person more likely to get heart disease, high blood sugar problems and different kind of cancers. N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase glutathione levels in the body. The diet supplement called ProImmune is also changed by the body into glutathione. Therefore, the purpose of this study is to find out the effect of ProImmune in healthy people. This study will also help to prove whether or not the ProImmune is able to improve the blood levels of glutathione in healthy people.

Interventions

Placebo low doseDrug
N Acetyl cysteine, 600mg (low dose)Drug
Proimmune 200 (FT061452) 3000mg low doseDrug
Placebo (high dose)Drug
N Acetyl cysteine, 1200mg (high dose)Drug
FT061452, 6000mg high doseDrug

Arms6

Placebo comparator
Placebo low dose
Placebo for low dose group given as a single dose.
Active comparator
N Acetyl cysteine, 600mg (low dose)
N-Acetyl Cysteine (NAC)600 mg (low dose) given as a single dose.
Active comparator
Proimmune 200(FT061452)
Proimmune 200(FT061452) low dose group 3000 mg given as a single dose.
Placebo comparator
Placebo high dose
Placebo given to high dose group given as a single dose.
Active comparator
N Acetyly cysteine, 1200mg (high dose)
N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
Active comparator
FT061452, 6000mg high dose
Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.

Primary outcomes1

Outcomes the sponsor listed as primary.

Intracellular Glutathione Level
Time frame · 6 hours
Registry description
Mean intracellular glutathione level every 2 hour

Secondary outcomes(1)

Augmentation Index
Time frame · Baseline and 6 hours
Registry description
Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection" if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 hours

Intracellular Glutathione Level

Group	Value (µmol/L)	Spread
Placebo-A	221.5	133.7
N Acetyl Cysteine-A	118.5	131.2
Proimmune 200-A	508.5	493.3
Placebo-B	358.0	116.9
N Acetyl Cysteine-B	147.8	86.8
Proimmune 200-B	132.8	168.3

Secondary and other outcome results(1)

Secondary outcomeMean· Baseline and 6 hours

Augmentation Index

Group	Value (percentage of the central pulse pressure)	Spread
Placebo-A	20	5.0
N Acetyl Cysteine-A	19.8	10.2
Proimmune 200-A	28.5	12.7
Placebo-B	27	10.8
N Acetyl Cysteine-B	20.3	11.9
Proimmune 200-B	26.5	6.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo-Alow dose group	–	0 / 4	0 / 4
N Acetyl Cysteine-AN Acetyl cysteine low dose group	–	0 / 4	0 / 4
Proimmune 200-AProimmune 200 low dose group	–	0 / 4	0 / 4
Placebo-BHigh dose group	–	0 / 4	0 / 4
N Acetyl Cysteine-BN Acetyl Cysteine High dose group	–	0 / 4	0 / 4
Proimmune 200-BProimmune 200 High dose group	–	0 / 4	0 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Subjects will be healthy male or female, 30 to 65 years of age. 2. Subjects must have a BMI between 20 and 35. 3. Subjects must be able to provide informed consent after risks and benefits have been explained. 4. Subjects must be non-smoking (defined as a subject who has not smoked for ≥ 6 months), and must agree to abstain from caffeine 72 hours prior to study day. 5. Subjects are in generally good health, based on pre-study medical history, physical examination and routine laboratory tests. 6. Subjects have, in the Investigator's opinion, no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinic. Exclusion Criteria: 1. Subjects who have a history of drug or alcohol abuse within 6 months of study screening, as determined by the Investigator. 2. Subjects who have participated in any investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose). 3. Subjects who have clinically significant medical or psychiatric illnesses currently or within 30 days of start of study (time of first dose), as determined by 3. the Investigator. 4. Subjects who have had symptoms of any significant acute illness within 30 days prior to the start of study (time of first dose), 5. Subjects who have any condition that interferes with their ability to understand or comply with the requirements of the study. 6. Females who are pregnant or nursing or have a high likelihood of becoming pregnant during the study.

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