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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charles Drew University of Medicine and Science
• Treatments: Acetylcysteine; N-monoacetylcystine

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.