Trial Outcomes & Findings for Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis (NCT NCT01130844)
NCT ID: NCT01130844
Last Updated: 2021-06-14
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
MMX Mesalamine (30mg/kg)
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
9
|
|
Overall Study
COMPLETED
|
21
|
22
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.0 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 2.59 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 3.28 • n=5 Participants
|
13.3 years
STANDARD_DEVIATION 3.06 • n=4 Participants
|
|
Age, Customized
5 to 17 years, inclusive
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7Population: The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
|
21411 ug*h/L
Standard Deviation 11081
|
46173 ug*h/L
Standard Deviation 22864
|
49213 ug*h/L
Standard Deviation 17664
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
|
1884 ug/L
Standard Deviation 1018
|
3825 ug/L
Standard Deviation 1979
|
4314 ug/L
Standard Deviation 2602
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
|
6.00 hours
Interval 0.0 to 24.0
|
8.98 hours
Interval 0.0 to 24.0
|
1.98 hours
Interval 0.0 to 24.0
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Clearance of a substance from the blood by the kidneys.
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
|
6.48 L/h
Standard Deviation 2.99
|
5.94 L/h
Standard Deviation 2.95
|
4.95 L/h
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
|
30942 ug*h/L
Standard Deviation 13743
|
58119 ug*h/L
Standard Deviation 22729
|
63067 ug*h/L
Standard Deviation 21752
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
|
2396 ug/L
Standard Deviation 1217
|
4113 ug/L
Standard Deviation 1641
|
4968 ug/L
Standard Deviation 2911
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
|
9.00 hours
Interval 0.0 to 24.0
|
7.48 hours
Interval 0.0 to 24.0
|
1.98 hours
Interval 0.0 to 24.0
|
PRIMARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
|
16.2 L/h
Standard Deviation 6.72
|
12.2 L/h
Standard Deviation 4.43
|
10.0 L/h
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + \[0.7847\* Xu0-24h Ac-5-ASA\])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
|
29.4 percentage of dose absorbed
Standard Deviation 14.5
|
27.0 percentage of dose absorbed
Standard Deviation 13.5
|
22.1 percentage of dose absorbed
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
|
162 mg
Standard Deviation 132
|
298 mg
Standard Deviation 221
|
235 mg
Standard Deviation 121
|
SECONDARY outcome
Timeframe: Over a 24-hour period starting on day 7Population: PKS
Outcome measures
| Measure |
MMX Mesalamine (30mg/kg)
n=21 Participants
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (60 mg/kg)
n=22 Participants
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
MMX Mesalamine (100 mg/kg)
n=9 Participants
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
|
|---|---|---|---|
|
Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
|
532 mg
Standard Deviation 411
|
708 mg
Standard Deviation 341
|
593 mg
Standard Deviation 251
|
Adverse Events
MMX Mesalamine (30mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMX Mesalamine (60 mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMX Mesalamine (100 mg/kg)
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 If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER