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NCT03878693 Clinical Trial

4-methylpyrazole and Acetaminophen Metabolism

Healthy Adult Volunteers Clinical Trial

Official title:
The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03878693
Other study ID # 1805526976
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 1, 2018
Est. completion date October 31, 2018

Study information
Verified date June 2018
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fomepizole
IV 4-MP.
• APAP
Oral APAP

Locations
Country Name City State
United States BUMCP - Department of Medical Toxicology Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxidative metabolism of APAP Measurement of oxidized metabolites of APAP 24 hours
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