Trial Outcomes & Findings for Effect on Acetaminophen Metabolism by Liquid Formulations (NCT NCT01246713)
NCT ID: NCT01246713
Last Updated: 2017-05-08
Results Overview
Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
8 hours
Results posted on
2017-05-08
Participant Flow
Whether subjects received the solid or liquid preparation initially was randomly chosen.
Participant milestones
| Measure |
Solid Acetaminophen First, Then Liquid Acetaminophen
Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
|
Liquid Acetaminophen First, Then Solid Acetaminophen
Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
|
|---|---|---|
|
First Acetaminophen Dosing (1 Day)
STARTED
|
6
|
9
|
|
First Acetaminophen Dosing (1 Day)
COMPLETED
|
6
|
9
|
|
First Acetaminophen Dosing (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 14 Days)
STARTED
|
6
|
9
|
|
Washout (at Least 14 Days)
COMPLETED
|
6
|
9
|
|
Washout (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Acetaminophen Dosing (1 Day)
STARTED
|
6
|
9
|
|
Second Acetaminophen Dosing (1 Day)
COMPLETED
|
6
|
9
|
|
Second Acetaminophen Dosing (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect on Acetaminophen Metabolism by Liquid Formulations
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursArea-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.
Outcome measures
| Measure |
Acetaminophen Solid Formulation
n=15 Participants
Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
|
Acetaminophen Liquid Formulation
n=15 Participants
Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
|
|---|---|---|
|
Acetaminophen Metabolites
|
2.411 mcg.hr/ml
Standard Error 0.21
|
2.009 mcg.hr/ml
Standard Error 0.17
|
Adverse Events
Solid Acetaminophen First, Then Liquid Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liquid Acetaminophen First, Then Solid Acetaminophen
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place