4-methylpyrazole and Acetaminophen Meta… | Clinical Trial

Key information

Conditions

Healthy Adult Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

BUMCP - Department of Medical Toxicology

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fomepizole

Drug

IV 4-MP.

APAP

Drug

Oral APAP

Primary outcomes

Oxidative metabolism of APAP

Time frame: 24 hours

Measurement of oxidized metabolites of APAP

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 18, 2019
Registry last updated: Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed