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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naureen Tareen, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT01251315
First received: November 29, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Oxidative Stress
Drug: Placebo low dose
Drug: N Acetyl cysteine, 600mg (low dose)
Drug: Proimmune 200 (FT061452) 3000mg low dose
Drug: Placebo (high dose)
Drug: N Acetyl cysteine, 1200mg (high dose)
Drug: FT061452, 6000mg high dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PILOT: The Effects of Short Term Administration of a Novel Glutathione Precursor (FT061452), on Serum and Intracellular Glutathione Levels

Resource links provided by NLM:


Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Intracellular Glutathione Level [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    Mean intracellular glutathione level every 2 hour


Secondary Outcome Measures:
  • Augmentation Index [ Time Frame: Baseline and 6 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo low dose
Placebo for low dose group given as a single dose.
Drug: Placebo low dose
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.
Other Name: Cellulose
Active Comparator: N Acetyl cysteine, 600mg (low dose)
N-Acetyl Cysteine (NAC)600 mg (low dose) given as a single dose.
Drug: N Acetyl cysteine, 600mg (low dose)
The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).
Other Name: NAC
Active Comparator: Proimmune 200(FT061452)
Proimmune 200(FT061452) low dose group 3000 mg given as a single dose.
Drug: Proimmune 200 (FT061452) 3000mg low dose
The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose'
Other Name: Proimmune-200 (FT061452)
Placebo Comparator: Placebo high dose
Placebo given to high dose group given as a single dose.
Drug: Placebo (high dose)
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.
Other Name: Cellulose
Active Comparator: N Acetyly cysteine, 1200mg (high dose)
N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
Drug: N Acetyl cysteine, 1200mg (high dose)
N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
Other Name: NAC
Active Comparator: FT061452, 6000mg high dose
Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.
Drug: FT061452, 6000mg high dose
Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.
Other Name: Proimmune-200 (Glutathione precursor)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251315

Locations
United States, California
Charles Drew University
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Naureen Tareen, MD Charles Drew University
  More Information

No publications provided

Responsible Party: Naureen Tareen, Principal Investigator, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT01251315     History of Changes
Other Study ID Numbers: 10 - 04 - 2268 - 01
Study First Received: November 29, 2010
Results First Received: July 15, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:
Glutathione
Antioxidant
Free radical
Oxidative stress
N-Acetyl Cysteine
Glutathione precursor

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014