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

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ClinicalTrials.gov Identifier: NCT01251315
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : March 17, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Naureen Tareen, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Oxidative Stress
Interventions 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
Enrollment 24
Recruitment Details The participants were recruited between may 2010 through June 2010. Healthy volunteers were recruited by physician referrals from community clinics.
Pre-assignment Details No enrolled participants were excluded.
Arm/Group Title Placebo Low Dose Group, Given Oral as a Single Dose N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose) Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose) Placebo High Dose Group, Given Oral as a Single Dose N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose) Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)
Hide Arm/Group Description Placebo low dose group, given oral as a single dose N Acetyl cysteine (low dose, 600mg oral as a single dose) Proimmune 200 (low dose, 3000 mg oral as a single dose) Placebo high dose group, given oral as a single dose N Acetyl cysteine (high dose 1200 mg oral as a single dose) Proimmune 200 (high dose, 6000 mg oral as a single dose)
Period Title: Overall Study
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Arm/Group Title Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B Total
Hide Arm/Group Description low dose oral x1 N Acetyl cysteine low dose group (600mg oral X1) Proimmune 200 low dose group (3000mg oral X 1) High dose oral X1 N Acetyl Cysteine High dose group ( 1200mg oral X1) Proimmune 200 High dose group (6000mg oral x1) Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 4 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
38.7  (6.4) 38.2  (3.8) 45.5  (12.9) 39.3  (6.8) 38.0  (5.8) 42.5  (9.2) 40  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
Female
1
  25.0%
1
  25.0%
2
  50.0%
3
  75.0%
1
  25.0%
2
  50.0%
10
  41.7%
Male
3
  75.0%
3
  75.0%
2
  50.0%
1
  25.0%
3
  75.0%
2
  50.0%
14
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 24 participants
4 4 4 4 4 4 24
1.Primary Outcome
Title Intracellular Glutathione Level
Hide Description Mean intracellular glutathione level every 2 hour
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Hide Arm/Group Description:
Placebo low dose group
N Acetyl cysteine low dose group
Proimmune 200 low dose group
Placebo High dose group
N Acetyl Cysteine High dose group
Proimmune 200 High dose group
Overall Number of Participants Analyzed 4 4 4 4 4 4
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 221.5  (133.7) 118.5  (131.2) 508.5  (493.3) 358.0  (116.9) 147.8  (86.8) 132.8  (168.3)
2 hour 242.3  (163.7) 121.8  (120.4) 342.8  (283.6) 347.8  (109.5) 149.5  (74.0) 311.8  (228.7)
4 hour 178.0  (146.8) 149.8  (167.1) 440.8  (419.9) 383.8  (159.2) 133.5  (75.4) 279.8  (228.7)
6 hour 236.5  (221.3) 103.5  (104.0) 317.8  (553.3) 355.0  (319.4) 125.0  (50.2) 274.0  (240.6)
2.Secondary Outcome
Title Augmentation Index
Hide 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.
Time Frame Baseline and 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Hide Arm/Group Description:
Placebo low dose group
N Acetyl cysteine low dose group ( 600mg oral x1)
Proimmune 200 low dose group ( 3000mg oral x1)
Placebo High dose group
N Acetyl Cysteine High dose group (1200 mg oral x1)
Proimmune 200 High dose group (6000mg oral x1)
Overall Number of Participants Analyzed 4 4 4 4 4 4
Mean (Standard Deviation)
Unit of Measure: percentage of the central pulse pressure
Baseline 20  (5.0) 19.8  (10.2) 28.5  (12.7) 27  (10.8) 20.3  (11.9) 26.5  (6.0)
6 hour 11.3  (8.4) 11.3  (6.9) 19  (10.4) 24.8  (5.3) 17.5  (15.7) 19.3  (6.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Hide Arm/Group Description low dose group N Acetyl cysteine low dose group Proimmune 200 low dose group High dose group N Acetyl Cysteine High dose group Proimmune 200 High dose group
All-Cause Mortality
Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo-A N Acetyl Cysteine-A Proimmune 200-A Placebo-B N Acetyl Cysteine-B Proimmune 200-B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr .Naureen Tareen
Organization: Charles R Drew University of Medicine and Science
Phone: 323-568-3359
EMail: aaant@aol.com
Responsible Party: Naureen Tareen, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT01251315     History of Changes
Other Study ID Numbers: 10 - 04 - 2268 - 01
First Submitted: November 29, 2010
First Posted: December 1, 2010
Results First Submitted: July 15, 2013
Results First Posted: March 17, 2014
Last Update Posted: April 14, 2014