Trial Outcomes & Findings for Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics (NCT NCT00768716)

NCT ID: NCT00768716

Last Updated: 2019-05-23

Results Overview

Plasma total clearance of acetaminophen in plasma measured by HPLC

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 95 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2019-05-23

Participant Flow

Participant milestones

Measure	White Subjects 2 x 500 mg acetaminophen by mouth once Acetaminophen: 2 x 500 mg by mouth once	Black Subjects 2 x 500 mg acetaminophen by mouth once Acetaminophen: 2 x 500 mg by mouth once
Overall Study STARTED	54	41
Overall Study COMPLETED	54	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics

Baseline characteristics by cohort

Measure	White Subjects n=54 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=41 Participants 2 x 500 mg acetaminophen by mouth once	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	41 Participants n=7 Participants	95 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	18 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	0 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Plasma total clearance of acetaminophen in plasma measured by HPLC

Outcome measures

Measure	White Subjects n=54 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=41 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 UGT2B15 genotype
Acetaminophen Plasma Clearance Association With Race/Ethnicity	5.3 mL/min/kg Interval 4.8 to 6.4	5.9 mL/min/kg Interval 5.1 to 6.9	—

PRIMARY outcome

Timeframe: 2 days

Acetaminophen glucuronidation partial clearance determined from plasma clearance and urinary metabolite excretion

Outcome measures

Measure	White Subjects n=54 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=41 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 UGT2B15 genotype
Acetaminophen Glucuronidation Partial Clearance Association With Race/Ethnicity	2.9 mL/min/kg Interval 2.3 to 3.8	3.3 mL/min/kg Interval 2.4 to 4.1	—

PRIMARY outcome

Timeframe: 2 days

Acetaminophen sulfation partial clearance determined from plasma clearance and urinary metabolite excretion

Outcome measures

Measure	White Subjects n=54 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=41 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 UGT2B15 genotype
Acetaminophen Sulfation Partial Clearance Association With Race/Ethnicity	1.4 mL/min/kg Interval 1.1 to 1.7	1.7 mL/min/kg Interval 1.3 to 2.2	—

PRIMARY outcome

Timeframe: 2 days

Acetaminophen oxidation partial clearance determined from plasma clearance and urinary metabolite excretion

Outcome measures

Measure	White Subjects n=54 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=41 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 UGT2B15 genotype
Acetaminophen Oxidation Partial Clearance Association With Race/Ethnicity	0.9 mL/min/kg Interval 0.65 to 1.15	0.57 mL/min/kg Interval 0.49 to 0.77	—

PRIMARY outcome

Timeframe: 2 days

The association of UGT2B15 genotype with acetaminophen total clearance

Outcome measures

Measure	White Subjects n=27 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=45 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 n=22 Participants UGT2B15 genotype
Acetaminophen Plasma Clearance Association With UGT2B15 Genotype	6.4 mL/min/kg Interval 5.4 to 7.7	5.5 mL/min/kg Interval 4.9 to 6.5	4.7 mL/min/kg Interval 4.2 to 5.3

PRIMARY outcome

Timeframe: 2 days

The association of acetaminophen glucuronidation partial clearance with UGT2B15 genotype

Outcome measures

Measure	White Subjects n=27 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=43 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 n=22 Participants UGT2B15 genotype
Acetaminophen Glucuronidation Partial Clearance Association With UGT2B15 Genotype	3.8 mL/min/kg Interval 2.7 to 4.0	2.8 mL/min/kg Interval 2.2 to 3.9	2.1 mL/min/kg Interval 1.4 to 2.7

PRIMARY outcome

Timeframe: 2 days

The association of UGT2B15 genotype with APAP plasma adduct concentrations

Outcome measures

Measure	White Subjects n=27 Participants 2 x 500 mg acetaminophen by mouth once	Black Subjects n=44 Participants 2 x 500 mg acetaminophen by mouth once	UGT2B15*2/*2 n=21 Participants UGT2B15 genotype
APAP Plasma Adduct Association With UGT2B15 Genotype	16 mL/min/kg Interval 11.0 to 23.0	19 mL/min/kg Interval 13.0 to 26.0	27 mL/min/kg Interval 21.0 to 35.0

Adverse Events

White Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Black Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Michael H. Court

Washington State University

Phone: 5093350817

Email: michael.court@wsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place