Trial Outcomes & Findings for The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels (NCT NCT01251315)

Results Overview

Mean intracellular glutathione level every 2 hour

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

6 hours

Results posted on

2014-04-14

Participant Flow

The participants were recruited between may 2010 through June 2010. Healthy volunteers were recruited by physician referrals from community clinics.

No enrolled participants were excluded.

Participant milestones

Participant milestones
Measure	Placebo Low Dose Group, Given Oral as a Single Dose Placebo low dose group, given oral as a single dose	N Acetyl Cysteine (Low Dose, 600mg 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) Proimmune 200 (low dose, 3000 mg oral as a single dose)	Placebo High Dose Group, Given 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) N Acetyl cysteine (high dose 1200 mg oral as a single dose)	Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose) Proimmune 200 (high dose, 6000 mg oral as a single dose)
Overall Study STARTED	4	4	4	4	4	4
Overall Study COMPLETED	4	4	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo-A n=4 Participants low dose oral x1	N Acetyl Cysteine-A n=4 Participants N Acetyl cysteine low dose group (600mg oral X1)	Proimmune 200-A n=4 Participants Proimmune 200 low dose group (3000mg oral X 1)	Placebo-B n=4 Participants High dose oral X1	N Acetyl Cysteine-B n=4 Participants N Acetyl Cysteine High dose group ( 1200mg oral X1)	Proimmune 200-B n=4 Participants Proimmune 200 High dose group (6000mg oral x1)	Total n=24 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 6.4 • n=5 Participants	38.2 years STANDARD_DEVIATION 3.8 • n=7 Participants	45.5 years STANDARD_DEVIATION 12.9 • n=5 Participants	39.3 years STANDARD_DEVIATION 6.8 • n=4 Participants	38.0 years STANDARD_DEVIATION 5.8 • n=21 Participants	42.5 years STANDARD_DEVIATION 9.2 • n=10 Participants	40 years STANDARD_DEVIATION 8.3 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	10 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	14 Participants n=115 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	4 participants n=10 Participants	24 participants n=115 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Intention-to-treat

Mean intracellular glutathione level every 2 hour

Outcome measures

Outcome measures
Measure	Placebo-A n=4 Participants Placebo low dose group	N Acetyl Cysteine-A n=4 Participants N Acetyl cysteine low dose group ( 600mg oral x1)	Proimmune 200-A n=4 Participants Proimmune 200 low dose group ( 3000mg oral x1)	Placebo-B n=4 Participants Placebo High dose group	N Acetyl Cysteine-B n=4 Participants N Acetyl Cysteine High dose group (1200 mg oral x1)	Proimmune 200-B n=4 Participants Proimmune 200 High dose group (6000mg oral x1)
Intracellular Glutathione Level 4 hour	178.0 µmol/L Standard Deviation 146.8	149.8 µmol/L Standard Deviation 167.1	440.8 µmol/L Standard Deviation 419.9	383.8 µmol/L Standard Deviation 159.2	133.5 µmol/L Standard Deviation 75.4	279.8 µmol/L Standard Deviation 228.7
Intracellular Glutathione Level Baseline	221.5 µmol/L Standard Deviation 133.7	118.5 µmol/L Standard Deviation 131.2	508.5 µmol/L Standard Deviation 493.3	358.0 µmol/L Standard Deviation 116.9	147.8 µmol/L Standard Deviation 86.8	132.8 µmol/L Standard Deviation 168.3
Intracellular Glutathione Level 2 hour	242.3 µmol/L Standard Deviation 163.7	121.8 µmol/L Standard Deviation 120.4	342.8 µmol/L Standard Deviation 283.6	347.8 µmol/L Standard Deviation 109.5	149.5 µmol/L Standard Deviation 74.0	311.8 µmol/L Standard Deviation 228.7
Intracellular Glutathione Level 6 hour	236.5 µmol/L Standard Deviation 221.3	103.5 µmol/L Standard Deviation 104.0	317.8 µmol/L Standard Deviation 553.3	355.0 µmol/L Standard Deviation 319.4	125.0 µmol/L Standard Deviation 50.2	274.0 µmol/L Standard Deviation 240.6

SECONDARY outcome

Timeframe: Baseline and 6 hours

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.