A Phase 4 interventional study of acetaminophen in Drug Induced Liver Injury, sponsored by Kennon Heard. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-12.
Sponsored by Kennon Heard · Phase 4 and Interventional
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 36 interventional studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →This is the only study on the registry with Kennon Heard as lead sponsor.
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Exclusion Criteria:
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Drug: acetaminophen
4 g/day for 10 consecutive days
Also known as: Tylenol Extra Strength
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.
Time frame: Day 0, 4, 7, 9, 11, and 14.
Alanine Aminotransferase (ALT)
ALT was measured at Day 0, 4, 7, 9, 11, and 14.
Time frame: Day 0, 4, 7, 9, 11, and 14.
Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.
| Milestone | Acetaminophen |
|---|---|
| Started | 27 |
| Completed | 24 |
| Not completed | 3 |
| Withdrew: Protocol violation | 3 |
Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.
| nmol/mL | Acetaminophen |
|---|---|
| Day 0 | 0.0 ± 0.0 |
| Day 4 | 0.3 ± 0.1 |
| Day 7 | 0.3 ± 0.2 |
| Day 9 | 0.4 ± 0.2 |
| Day 11 | 0.4 ± 0.2 |
| Day 14 | 0.2 ± 0.1 |
ALT was measured at Day 0, 4, 7, 9, 11, and 14.
| IU/L | Acetaminophen |
|---|---|
| Day 0 | 24.0 ± 8.1 |
| Day 4 | 25.9 ± 10.1 |
| Day 7 | 41.3 ± 27.3 |
| Day 9 | 41.3 ± 27.3 |
| Day 11 | 41.8 ± 24.2 |
| Day 14 | 36.1 ± 18.6 |
Collected over Adverse events were collected from time of first dose of study medication through followup visits.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acetaminophen | — | 0/27 (0%) | 12/27 (44.4%) |
| Event | Acetaminophen |
|---|---|
| nauseaGastrointestinal disorders | 5/27 |
| headacheNervous system disorders | 3/27 |
| diarrhoeaGastrointestinal disorders | 2/27 |
| fatigueGeneral disorders | 2/27 |
| migraineNervous system disorders | 2/27 |
| Age, Categorical(Participants) | Acetaminophen |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 0 |
| Age Continuous(years) | Acetaminophen |
|---|---|
| Mean | 37.3 ± 12.2 |
| Sex: Female, Male(Participants) | Acetaminophen |
|---|---|
| Female | 19 |
| Male | 8 |
| Region of Enrollment(participants) | Acetaminophen |
|---|---|
| United States | 27 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Chemical and Drug Induced Liver Injury→