Clinical Trials Logo
  1. Home
  2. Healthy Adult Volunteers
  3. NCT03878693
  4. Details
NCT03878693 Clinical Trial

4-methylpyrazole and Acetaminophen Metabolism

Healthy Adult Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03878693
Other study ID # 1805526976
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 1, 2018
Est. completion date October 31, 2018

Study information
Verified date June 2018
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fomepizole
IV 4-MP.
• APAP
Oral APAP

Locations
Country Name City State
United States BUMCP - Department of Medical Toxicology Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxidative metabolism of APAP Measurement of oxidized metabolites of APAP 24 hours
See also
  Status Clinical Trial Phase
Withdrawn NCT06034899 - A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants Phase 1
Completed NCT05162274 - Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers. Phase 1
Completed NCT03748758 - Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers Phase 1
Recruiting NCT06008652 - A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers Phase 1
Terminated NCT02079480 - Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects Phase 1
Completed NCT01657838 - Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects Phase 1
Completed NCT01651325 - Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects Phase 1
Completed NCT01354379 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer Phase 1
Completed NCT01129466 - Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers N/A
Completed NCT04856969 - Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers Phase 1
Completed NCT01333462 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Phase 1
Completed NCT02942771 - A MAD Study of TT301/MW189 in Healthy Volunteers Phase 1
Completed NCT02822898 - Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults Phase 4
Completed NCT05017987 - Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 Phase 1
Not yet recruiting NCT05757596 - Study of VSA001 Injection in Chinese Healthy Adult Volunteers Phase 1
Completed NCT05074368 - Efficacy and Safety of Heterologous and Homologous COVID-19 Vaccination N/A
Completed NCT01672242 - Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®) N/A
Completed NCT04204772 - A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers Early Phase 1
Completed NCT05154461 - Intestinal Ketone Bodies Interfere With the Glycemic Control N/A
Active, not recruiting NCT02058472 - Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers Phase 1