Hemin in Healthy Subjects

NCT00882804 | Completed Phase 1

• 1 other identifier: 09-000230
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

hemin, heme oxygenase, humans, HO-1

Outcome Measures

Primary Outcomes (3)

• Venous carboxyhemoglobin concentrations

  at 6 hours

• HO-1 protein concentration in leukocytes from venous blood

  at 6 hours

• Serum bilirubin

  at 6 hours

Secondary Outcomes (3)

• Venous carboxyhemoglobin concentrations

  at 4, 24, and 48 hours

• HO-1 activity in leukocytes from venous blood

  at 4, 24, and 48 hours

• Serum bilirubin

  at 4, 24, and 48 hours

Study Arms (2)

Hemin

EXPERIMENTAL

Drug: Hemin infusion

placebo

PLACEBO COMPARATOR

Drug: placebo infusion

Interventions

Hemin infusion DRUG

Hemin (Panhematin®, Ovation Pharmaceuticals, Deerfield, IL) will be administered through a large-caliber peripheral vein at a dose of 1.25 mL/kg and at a rate of 60 mL/hour. To enhance stability, Panhematin® will be diluted in \~ 132 mL of 25% albumin to obtain a hemin concentration of 2.4 mg/mL.

Hemin

placebo infusion DRUG

25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Adil E Bharucha, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 17, 2009

Record last verified: 2009-04

Locations

US (1)