Trial Outcomes & Findings for Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce (NCT NCT01130051)
NCT ID: NCT01130051
Last Updated: 2011-05-12
Results Overview
The maximum or peak concentration that Colcrys® reaches in the plasma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
Results posted on
2011-05-12
Participant Flow
Participant milestones
| Measure |
Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce
On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
|
Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab
On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
|
|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 14 Days
STARTED
|
8
|
8
|
|
Washout Period of 14 Days
COMPLETED
|
7
|
6
|
|
Washout Period of 14 Days
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
7
|
6
|
|
Period 2
COMPLETED
|
7
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce
On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
|
Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab
On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
|
|---|---|---|
|
Washout Period of 14 Days
Withdrawal by Subject
|
0
|
1
|
|
Washout Period of 14 Days
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Baseline characteristics by cohort
| Measure |
Colcrys® Intact Tab and Colcrys® in Applesauce
n=16 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
37.812 years
STANDARD_DEVIATION 13.332 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administrationPopulation: Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.
The maximum or peak concentration that Colcrys® reaches in the plasma
Outcome measures
| Measure |
Colcrys® 0.6 mg Administered as an Intact Tablet
n=13 Participants
Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
|
Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce
n=13 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
3.087 ng/mL
Standard Deviation 0.953
|
2.616 ng/mL
Standard Deviation 0.785
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administrationPopulation: Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule
Outcome measures
| Measure |
Colcrys® 0.6 mg Administered as an Intact Tablet
n=13 Participants
Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
|
Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce
n=13 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
23.042 ng-hr/mL
Standard Deviation 6.100
|
19.216 ng-hr/mL
Standard Deviation 4.512
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administrationPopulation: Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colcrys® 0.6 mg Administered as an Intact Tablet
n=13 Participants
Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
|
Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce
n=13 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
28.550 ng-hr/mL
Standard Deviation 8.597
|
23.883 ng-hr/mL
Standard Deviation 6.102
|
Adverse Events
Colcrys® 0.6 mg Tablet Administered Intact
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colcrys® 0.6 mg Tablet Administered Intact
n=14 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
|
Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce
n=15 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/14
One subject withdrew voluntarily from the study and one was discontinued for protocol violations after receiving the test formulation. One subject was discontinued for protocol violations after receiving the reference formulation.
|
6.7%
1/15 • Number of events 1
One subject withdrew voluntarily from the study and one was discontinued for protocol violations after receiving the test formulation. One subject was discontinued for protocol violations after receiving the reference formulation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60