NCT01251315

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 17, 2014

Completed
Last Updated

April 14, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

November 29, 2010

Results QC Date

July 15, 2013

Last Update Submit

March 17, 2014

Conditions

Oxidative Stress

Keywords

GlutathioneAntioxidantFree radicalOxidative stressN-Acetyl CysteineGlutathione precursor

Outcome Measures

Primary Outcomes (1)

  • Intracellular Glutathione Level

    Mean intracellular glutathione level every 2 hour

    6 hours

Secondary Outcomes (1)

  • Augmentation Index

    Baseline and 6 hours

Study Arms (6)

Placebo low dose

PLACEBO COMPARATOR

Placebo for low dose group given as a single dose.

Drug: Placebo low dose

N Acetyl cysteine, 600mg (low dose)

ACTIVE COMPARATOR

N-Acetyl Cysteine (NAC)600 mg (low dose) given as a single dose.

Drug: N Acetyl cysteine, 600mg (low dose)

Proimmune 200(FT061452)

ACTIVE COMPARATOR

Proimmune 200(FT061452) low dose group 3000 mg given as a single dose.

Drug: Proimmune 200 (FT061452) 3000mg low dose

Placebo high dose

PLACEBO COMPARATOR

Placebo given to high dose group given as a single dose.

Drug: Placebo (high dose)

N Acetyly cysteine, 1200mg (high dose)

ACTIVE COMPARATOR

N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.

Drug: N Acetyl cysteine, 1200mg (high dose)

FT061452, 6000mg high dose

ACTIVE COMPARATOR

Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.

Drug: FT061452, 6000mg high dose

Interventions

Placebo low doseDRUG

This is a prospective randomized controlled pilot study, which will include twenty-four (24) healthy individuals.The first 12 subjects (low dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.

Also known as: Cellulose
Placebo low dose
N Acetyl cysteine, 600mg (low dose)DRUG

The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).

Also known as: NAC
N Acetyl cysteine, 600mg (low dose)
Proimmune 200 (FT061452) 3000mg low doseDRUG

The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose'

Also known as: Proimmune-200 (FT061452)
Proimmune 200(FT061452)
Placebo (high dose)DRUG

The second sub set of 12 subjects (high dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.

Also known as: Cellulose
Placebo high dose
N Acetyl cysteine, 1200mg (high dose)DRUG

N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.

Also known as: NAC
N Acetyly cysteine, 1200mg (high dose)
FT061452, 6000mg high doseDRUG

Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.

Also known as: Proimmune-200 (Glutathione precursor)
FT061452, 6000mg high dose

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be healthy male or female, 30 to 65 years of age.
  • Subjects must have a BMI between 20 and 35.
  • Subjects must be able to provide informed consent after risks and benefits have been explained.
  • 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.
  • Subjects are in generally good health, based on pre-study medical history, physical examination and routine laboratory tests.
  • 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.

You may not qualify if:

  • Subjects who have a history of drug or alcohol abuse within 6 months of study screening, as determined by the Investigator.
  • 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).
  • 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.
  • Subjects who have had symptoms of any significant acute illness within 30 days prior to the start of study (time of first dose),
  • Subjects who have any condition that interferes with their ability to understand or comply with the requirements of the study.
  • Females who are pregnant or nursing or have a high likelihood of becoming pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University

Los Angeles, California, 90059, United States

Location

MeSH Terms

Interventions

CelluloseAcetylcysteine

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr .Naureen Tareen
Organization
Charles R Drew University of Medicine and Science
aaant@aol.com
323-568-3359

Study Officials

  • Naureen Tareen, MD

    Charles Drew University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 1, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 14, 2014

Results First Posted

March 17, 2014

Record last verified: 2014-03

Locations

US(1)