Trial Outcomes & Findings for Healthy and Renal Impairment Study of Colcrys (Colchicine, USP) (NCT NCT01084278)
NCT ID: NCT01084278
Last Updated: 2012-10-12
Results Overview
The maximum or peak concentration of colchicine in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose
Results posted on
2012-10-12
Participant Flow
Participants took part in the study at three investigative sites in the United States from 25 May 2010 to 28 February 2011.
Healthy participants, participants with mild, moderate or severe renal impairment and participants with end stage renal disease (requiring hemodialysis) were stratified to one of five treatment groups based on their renal status. All participants received 0.6 mg colchicine.
Participant milestones
| Measure |
Healthy
Healthy participants with normal renal function (Creatinine Clearance \[CrCl\] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Mild
Participants with mild renal impairment (estimated Glomerular Filtration Rate \[eGFR\] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Severe
Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
ESRD
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
Baseline characteristics by cohort
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function (Creatinine Clearance \[CrCl\] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment (estimated Glomerular Filtration Rate \[eGFR\] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
ESRD
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
52.5 years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 3.94 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 8.48 • n=4 Participants
|
42.2 years
STANDARD_DEVIATION 12.85 • n=21 Participants
|
55.85 years
STANDARD_DEVIATION 10.96 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
8 participants
n=21 Participants
|
28 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
40 participants
n=8 Participants
|
|
Child Bearing Potential
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Child Bearing Potential
No
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
17 participants
n=8 Participants
|
|
Creatinine Clearance/estimated Glomerular Filtration Rate
|
111.49 mL/min
STANDARD_DEVIATION 22.651 • n=5 Participants
|
73.3 mL/min
STANDARD_DEVIATION 8.10 • n=7 Participants
|
40.0 mL/min
STANDARD_DEVIATION 6.78 • n=5 Participants
|
22 mL/min
STANDARD_DEVIATION 4.17 • n=4 Participants
|
10.9 mL/min
STANDARD_DEVIATION 2.97 • n=21 Participants
|
55.70 mL/min
STANDARD_DEVIATION 36.61 • n=8 Participants
|
|
Height
|
170.33 cm
STANDARD_DEVIATION 7.722 • n=5 Participants
|
167.94 cm
STANDARD_DEVIATION 8.865 • n=7 Participants
|
164.83 cm
STANDARD_DEVIATION 9.054 • n=5 Participants
|
172.06 cm
STANDARD_DEVIATION 8.643 • n=4 Participants
|
168.05 cm
STANDARD_DEVIATION 11.991 • n=21 Participants
|
169.09 cm
STANDARD_DEVIATION 9.27 • n=8 Participants
|
|
Weight
|
77.09 kg
STANDARD_DEVIATION 8.494 • n=5 Participants
|
65.55 kg
STANDARD_DEVIATION 9.904 • n=7 Participants
|
77.55 kg
STANDARD_DEVIATION 10.667 • n=5 Participants
|
100.81 kg
STANDARD_DEVIATION 16.856 • n=4 Participants
|
73.86 kg
STANDARD_DEVIATION 22.287 • n=21 Participants
|
78.95 kg
STANDARD_DEVIATION 18.47 • n=8 Participants
|
|
Body Mass Index (BMI)
|
26.54 kg/m^2
STANDARD_DEVIATION 2.113 • n=5 Participants
|
23.18 kg/m^2
STANDARD_DEVIATION 2.560 • n=7 Participants
|
28.64 kg/m^2
STANDARD_DEVIATION 4.823 • n=5 Participants
|
33.96 kg/m^2
STANDARD_DEVIATION 4.489 • n=4 Participants
|
25.66 kg/m^2
STANDARD_DEVIATION 5.018 • n=21 Participants
|
27.60 kg/m^2
STANDARD_DEVIATION 5.28 • n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dosePopulation: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The maximum or peak concentration of colchicine in the plasma.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2.43 ng/mL
Standard Deviation 0.68
|
2.73 ng/mL
Standard Deviation 0.78
|
3.69 ng/mL
Standard Deviation 1.42
|
2.53 ng/mL
Standard Deviation 0.73
|
2.67 ng/mL
Standard Deviation 0.94
|
2.27 ng/mL
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dosePopulation: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The time to reach the maximum or peak concentration of colchicine in the plasma.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
1.31 hours
Standard Deviation 0.37
|
1.01 hours
Standard Deviation 0.04
|
1.31 hours
Standard Deviation 0.37
|
1.58 hours
Standard Deviation 0.68
|
1.31 hours
Standard Deviation 0.46
|
1.29 hours
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dosePopulation: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)
|
23.37 ng*h/mL
Standard Deviation 7.75
|
25.83 ng*h/mL
Standard Deviation 5.43
|
43.94 ng*h/mL
Standard Deviation 11.68
|
40.44 ng*h/mL
Standard Deviation 13.58
|
26.09 ng*h/mL
Standard Deviation 8.73
|
22.65 ng*h/mL
Standard Deviation 8.54
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)
|
24.73 ng*h/mL
Standard Deviation 8.10
|
27.21 ng*h/mL
Standard Deviation 5.56
|
48.94 ng*h/mL
Standard Deviation 13.45
|
48.00 ng*h/mL
Standard Deviation 17.36
|
31.68 ng*h/mL
Standard Deviation 12.28
|
30.61 ng*h/mL
Standard Deviation 17.29
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Apparent First-order Terminal Elimination Rate Constant (Kel)
|
0.023 1/hr
Standard Deviation 0.004
|
0.023 1/hr
Standard Deviation 0.003
|
0.018 1/hr
Standard Deviation 0.002
|
0.014 1/hr
Standard Deviation 0.002
|
0.025 1/hr
Standard Deviation 0.006
|
0.020 1/hr
Standard Deviation 0.007
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Apparent First-order Terminal Elimination Half-life (t½)
|
30.63 hr
Standard Deviation 5.43
|
30.92 hr
Standard Deviation 3.54
|
39.90 hr
Standard Deviation 3.93
|
49.53 hr
Standard Deviation 6.01
|
29.38 hr
Standard Deviation 7.51
|
40.80 hr
Standard Deviation 21.71
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
The Apparent Total Volume of Distribution After Administration (V-area/F)
|
1131.68 L
Standard Deviation 247.32
|
1024.22 L
Standard Deviation 266.47
|
761.81 L
Standard Deviation 237.07
|
1009.02 L
Standard Deviation 419.88
|
870.46 L
Standard Deviation 230.68
|
1263.0 L
Standard Deviation 462.40
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)
|
14.84 L/kg
Standard Deviation 3.36
|
15.80 L/kg
Standard Deviation 3.94
|
10.06 L/kg
Standard Deviation 3.65
|
9.91 L/kg
Standard Deviation 3.10
|
13.35 L/kg
Standard Deviation 6.94
|
18.91 L/kg
Standard Deviation 11.91
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance of Colchicine
|
26.34 L/hr
Standard Deviation 7.57
|
23.04 L/hr
Standard Deviation 5.60
|
13.63 L/hr
Standard Deviation 5.80
|
14.59 L/hr
Standard Deviation 7.37
|
22.07 L/hr
Standard Deviation 9.87
|
25.78 L/hr
Standard Deviation 15.08
|
PRIMARY outcome
Timeframe: Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
n=8 Participants
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Weight-adjusted Apparent Total Body Clearance of Colchicine
|
0.34 L/hr/kg
Standard Deviation 0.08
|
0.36 L/hr/kg
Standard Deviation 0.12
|
0.18 L/hr/kg
Standard Deviation 0.09
|
0.14 L/hr/kg
Standard Deviation 0.06
|
0.35 L/hr/kg
Standard Deviation 0.26
|
0.41 L/hr/kg
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and up to 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Amount of Colchicine Excreted in Urine (Ae[0-t])
|
0.110 mg
Standard Deviation 0.032
|
0.100 mg
Standard Deviation 0.026
|
0.094 mg
Standard Deviation 0.053
|
0.058 mg
Standard Deviation 0.012
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and up to 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time
|
18.34 percent of dose
Standard Deviation 5.39
|
16.69 percent of dose
Standard Deviation 4.3
|
15.67 percent of dose
Standard Deviation 8.77
|
9.63 percent of dose
Standard Deviation 2.05
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1 and up to 120 hours post dose.Population: Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.
Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.
Outcome measures
| Measure |
Healthy
n=8 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 Participants
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 Participants
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 Participants
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Renal Clearance of Colchicine (CLR)
|
4.78 L/hr
Standard Deviation 0.51
|
3.90 L/hr
Standard Deviation 0.74
|
2.12 L/hr
Standard Deviation 0.86
|
1.69 L/hr
Standard Deviation 1.13
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15, post-dose during dialysisPopulation: ESRD participants on dialysis, where data were available.
The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.
Outcome measures
| Measure |
Healthy
n=7 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Dialysis Clearance of Colchicine (CLD)
|
7.4 L/h
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15, post-dose during dialysisPopulation: ESRD participants on dialysis, where data were available.
The cumulative percentage of the colchicine dose recovered in dialysate.
Outcome measures
| Measure |
Healthy
n=7 Participants
Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
|
Mild
Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
Severe
Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
|
ESRD - Off Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
|
ESRD - on Dialysis
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|---|
|
Percentage of Colchicine Dose Recovered in Dialysate
|
5.2 percent dose
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Healthy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mild
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Moderate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Severe
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ESRD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy
n=8 participants at risk
Healthy participants with normal renal function (Creatinine Clearance \[CrCl\] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Mild
n=8 participants at risk
Participants with mild renal impairment (estimated Glomerular Filtration Rate \[eGFR\] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Moderate
n=8 participants at risk
Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
Severe
n=8 participants at risk
Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
|
ESRD
n=8 participants at risk
Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site erythema
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site induration
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device complication
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From the first dose of study drug up to 6 days.
The investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER