Trial Outcomes & Findings for Bioavailability Study of Colcrys® in Apple Juice (NCT NCT01123395)
NCT ID: NCT01123395
Last Updated: 2011-05-03
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
2011-05-03
Participant Flow
Participant milestones
| Measure |
Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice
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 dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
|
Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab
On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice 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
|
8
|
7
|
|
Washout Period of 14 Days
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
8
|
7
|
|
Period 2
COMPLETED
|
8
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice
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 dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
|
Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab
On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice 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
|
Baseline Characteristics
Bioavailability Study of Colcrys® in Apple Juice
Baseline characteristics by cohort
| Measure |
Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice
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 dissolved in apple juice, following an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.44 years
STANDARD_DEVIATION 11.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 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 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.
The maximum or peak concentration that Colcrys® reaches in the plasma
Outcome measures
| Measure |
Colcrys® 0.6 mg Administered as an Intact Tablet
n=15 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 Dissolved in Apple Juice
n=15 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2.407 ng/mL
Standard Deviation 1.082
|
2.122 ng/mL
Standard Deviation 0.835
|
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 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.
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=15 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 Dissolved in Apple Juice
n=15 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice 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)]
|
17.686 ng-hr/mL
Standard Deviation 5.232
|
16.718 ng-hr/mL
Standard Deviation 4.222
|
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 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.
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=15 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 Dissolved in Apple Juice
n=15 Participants
Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
21.068 ng-hr/mL
Standard Deviation 5.510
|
21.890 ng-hr/mL
Standard Deviation 8.193
|
Adverse Events
Colcrys® 0.6 mg Tablet Administered Intact
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice
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=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 dissolved in apple juice, following an overnight fast of at least 10 hours.
|
Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice
n=16 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 dissolved in apple juice, following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Nervous system disorders
Headache ∗
|
6.7%
1/15 • Number of events 1
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
0.00%
0/16
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
|
Investigations
Increased Blood Pressure
|
6.7%
1/15 • Number of events 1
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
0.00%
0/16
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/15
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
6.2%
1/16 • Number of events 1
One participant withdrew from the study after receiving the the test formulation (Colcrys® 0.6 mg tablet crushed and dissolved in apple juice) in Period 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60