Hemin in Healthy Subjects
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Hemin infusion (Drug); placebo infusion (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Adil E Bharucha, M.D., Principal Investigator, Affiliation: Mayo Clinic
Summary
This study is being done because we want to learn if hemin can increase the production of
heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical,
chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the
Food and Drug Administration for treating acute porphyria, which is an inherited condition
caused by an enzyme deficiency.
Clinical Details
Official title: Effect of Hemin on Heme-Oxygenase-1 Activity in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary outcome: Venous carboxyhemoglobin concentrationsHO-1 protein concentration in leukocytes from venous blood Serum bilirubin
Secondary outcome: Venous carboxyhemoglobin concentrationsHO-1 activity in leukocytes from venous blood Serum bilirubin
Detailed description:
Heme-oxygenase 1 (HO-1) degrades heme, protects cells against oxidative stress, and is
beneficial in several experimental models but has not been pharmacologically activated in
humans. The objectives of this study were to evaluate the effects of hemin on HO-1 activity
in healthy subjects. Hemin is the most powerful inducer of HO-1. Hemin is FDA-approved to
treat acute intermittent porphyria. In addition, hemin has also been used to treat
thalassemia intermedia, myelodysplastic syndrome, and to control liver allograft failure due
to recurrence of erythropoietic prototheria. Our hypothesis is that compared to placebo,
hemin will increase HO-1 in humans. Ten healthy subjects will be randomized to hemin (n = 5,
Panhematin®, Ovation Pharmaceuticals, 3 mg/kg i. v. in 25% albumin) or placebo (n = 5, 25%
albumin) infusion. HO-1 activity will be assessed before and after (4, 6, 24, and 48 hours)
infusions.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
1. Healthy non pregnant not breast feeding, and non-smoking subjects aged 18 - 65 years
old without clinical evidence of significant cardiovascular, gastrointestinal,
hematological, neurological, psychiatric or other disease that may interfere with the
objectives of the study and/or pose safety concerns. No symptoms of functional GI
disorder as assessed by a validated questionnaire.
2. No medications except for stable doses of oral contraceptives or thyroid
supplementation. Because ascorbic acid can induce HO-1 activity, multivitamins will
need to be discontinued for 1 week before and for the duration of the study.
3. No intolerance or allergy to eggs
4. Able to provide written informed consent before participating in the study
5. Able to communicate adequately with the investigator and to comply with the
requirements for the entire study
6. Screening weight < 96 kg
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: February 2009
Last updated: April 16, 2009
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