NCT03878693

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

September 26, 2019

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

March 14, 2019

Last Update Submit

September 24, 2019

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

  • Oxidative metabolism of APAP

    Measurement of oxidized metabolites of APAP

    24 hours

Study Arms (2)

A

EXPERIMENTAL

Oral APAP and IV Fomepizole.

Drug: FomepizoleDrug: APAP

B

ACTIVE COMPARATOR

Oral APAP.

Drug: APAP

Interventions

FomepizoleDRUG

IV 4-MP.

A
APAPDRUG

Oral APAP

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating
  • History of alcohol abuse
  • Allergy to APAP or fomepizole
  • Screening LFTs above normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUMCP - Department of Medical Toxicology

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

  • Kang AM, Padilla-Jones A, Fisher ES, Akakpo JY, Jaeschke H, Rumack BH, Gerkin RD, Curry SC. The Effect of 4-Methylpyrazole on Oxidative Metabolism of Acetaminophen in Human Volunteers. J Med Toxicol. 2020 Apr;16(2):169-176. doi: 10.1007/s13181-019-00740-z. Epub 2019 Nov 25.

    PMID: 31768936DERIVED

MeSH Terms

Interventions

FomepizoleAcetaminophen

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

July 1, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

September 26, 2019

Record last verified: 2018-06

Locations

US(1)