4-methylpyrazole and Acetaminophen Metabolism

Early Phase 1

Completed

• Conditions: Healthy Adult Volunteers
• Interventions: Drug: APAP; Drug: Fomepizole

• Registration Number: NCT03878693
• Lead Sponsor: University of Arizona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-07-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B	APAP	Oral APAP.
A	Fomepizole	Oral APAP and IV Fomepizole.
A	APAP	Oral APAP and IV Fomepizole.

Primary Outcome Measures

Name	Time	Method
Oxidative metabolism of APAP	24 hours	Measurement of oxidized metabolites of APAP

Trial Locations

Locations (1)

BUMCP - Department of Medical Toxicology; 🇺🇸 Phoenix, Arizona, United States