4-methylpyrazole and Acetaminophen Metabolism

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03878693

Enrollment

Registered

2019-03-18

Start date

2018-07-01

Completion date

2018-10-31

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Volunteers

Brief summary

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

Interventions

DRUGFomepizole

IV 4-MP.

DRUGAPAP

Oral APAP

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Oxidative metabolism of APAP	24 hours	Measurement of oxidized metabolites of APAP

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026