4-methylpyrazole and Acetaminophen Metabolism

University of Arizona

Status and phase: Completed; Early Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: APAP; Drug: Fomepizole

Study type: Interventional

Funder types: Other

Identifiers

NCT03878693

1805526976

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

A

Experimental group

Description:

Oral APAP and IV Fomepizole.

Treatment:

Drug: Fomepizole

Drug: APAP

B

Active Comparator group

Description:

Oral APAP.

Treatment:

Drug: APAP