Healthy Adult VolunteersEarly Phase 1NCT03878693
4-methylpyrazole and Acetaminophen Metabolism
A Early Phase 1 study testing Fomepizole and APAP in people with Healthy Adult Volunteers, run by University of Arizona at 1 site in United States.
Trial summary
Oxidative metabolism of APAP will be studied with and without 4-MP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Fomepizole and APAP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Oct 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating
- History of alcohol abuse
- Allergy to APAP or fomepizole
- Screening LFTs above normal range
Trial locations and contacts
1 site in 1 country.
United States1 site
BUMCP - Department of Medical Toxicology
Phoenix, Arizona, 85006
About this study
Official title: The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers
Oxidative metabolism of APAP will be studied with and without 4-MP.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Fomepizole, APAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FomepizoleDrug
IV 4-MP.
APAPDrug
Oral APAP
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oral APAP and IV Fomepizole. Receives: Drug: Fomepizole; Drug: APAP |
| B | Active comparator | Oral APAP. Receives: Drug: APAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative metabolism of APAP
Measurement of oxidized metabolites of APAP
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jul 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878693
- Sponsor's protocol ID
- 1805526976
- Status last verified
- Jun 2018
- First submitted
- 14 Mar 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31768936
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03878693
- Acronym / sponsor ID
- 1805526976
- Conditions
- Healthy Adult Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxidative metabolism of APAP will be studied with and without 4-MP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fomepizole, Drug: APAPOral APAP and IV Fomepizole. |
| B | Active comparator | Drug: APAPOral APAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or lactating
- History of alcohol abuse
- Allergy to APAP or fomepizole
- Screening LFTs above normal range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FomepizoleIV 4-MP. | Drug | A |
| APAPOral APAP | Drug | A, B |
Primary outcome
Oxidative metabolism of APAP
Time frame: 24 hours
Measurement of oxidized metabolites of APAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 31768936Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fomepizole and APAP in people with Healthy Adult Volunteers, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative metabolism of APAP (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03878693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.