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4-methylpyrazole and Acetaminophen Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03878693
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
Oxidative metabolism of APAP will be studied with and without 4-MP.

Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Drug: Fomepizole Drug: APAP Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fomepizole

Arm Intervention/treatment
Experimental: A
Oral APAP and IV Fomepizole.
Drug: Fomepizole
IV 4-MP.

Drug: APAP

Active Comparator: B
Oral APAP.
Drug: APAP

Primary Outcome Measures :
  1. Oxidative metabolism of APAP [ Time Frame: 24 hours ]
    Measurement of oxidized metabolites of APAP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • No APAP use in previous 2 weeks
  • No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days
  • No allergy to APAP or fomepizole
  • BMI < 29

Exclusion Criteria:

  • Pregnant or lactating
  • History of alcohol abuse
  • Allergy to APAP or fomepizole
  • Screening LFTs above normal range

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03878693

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United States, Arizona
BUMCP - Department of Medical Toxicology
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
University of Arizona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Arizona Identifier: NCT03878693    
Other Study ID Numbers: 1805526976
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action