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NCT01251315 · ClinicalTrials.gov registry record · Phase 1
The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
A Phase 1 study, sponsored by Charles Drew University of Medicine and Science.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01251315: Completed Phase 1 study, sponsored by Charles Drew University of Medicine and Science.
NCT01251315 is a Phase 1 study that has completed, run by Charles Drew University of Medicine and Science. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251315, a Phase 1 study, has completed, sponsored by Charles Drew University of Medicine and Science.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
Mean intracellular glutathione level every 2 hour
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01251315 record still lists
NCT01251315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo low dose is the first listed.
NCT01251315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01251315 about?
NCT01251315 is a clinical study titled "The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels". 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...
What is the current status of trial NCT01251315?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-12. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01251315?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01251315?
This trial is sponsored by Charles Drew University of Medicine and Science, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01251315's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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