Trial Outcomes & Findings for Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions (NCT NCT01001052)
NCT ID: NCT01001052
Last Updated: 2010-09-28
Results Overview
The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
Results posted on
2010-09-28
Participant Flow
Participant milestones
| Measure |
Colcrys™ (Colchicine) - Young Subjects (18-30 Years)
All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)
All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
Baseline characteristics by cohort
| Measure |
Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects
n=38 Participants
Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 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
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
42.32 years
STANDARD_DEVIATION 19.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-doseThe maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.
Outcome measures
| Measure |
Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)
n=20 Participants
All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)
n=18 Participants
All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2.60 ng/mL
Standard Deviation 0.71
|
2.56 ng/mL
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-doseThe 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 plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)
n=20 Participants
All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)
n=18 Participants
All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™
|
22.39 ng*hr/mL
Standard Deviation 6.95
|
25.01 ng*hr/mL
Standard Deviation 6.92
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-doseThe area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)
n=20 Participants
All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)
n=18 Participants
All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™
|
20.14 ng*hr/mL
Standard Deviation 5.85
|
21.88 ng*hr/mL
Standard Deviation 6.22
|
Adverse Events
Colcrys™ - Young Subjects (18-30 Years)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Colcrys™ - Elderly Subjects (>60 Years Old)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colcrys™ - Young Subjects (18-30 Years)
n=20 participants at risk
All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
|
Colcrys™ - Elderly Subjects (>60 Years Old)
n=18 participants at risk
All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
|
|---|---|---|
|
Nervous system disorders
somnolence
|
5.0%
1/20 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Feeling hot
|
0.00%
0/20
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Number of events 1
|
38.9%
7/18 • Number of events 7
|
|
Investigations
Heart rate increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60