Trial Outcomes & Findings for Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration (NCT NCT01737944)
NCT ID: NCT01737944
Last Updated: 2014-02-25
Results Overview
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
24 Hour period
Results posted on
2014-02-25
Participant Flow
Subjects were screened and enrolled at 2 sites in the US. Approximately equal number of subjects on 10 mg, 15 mg, 20 mg and 25 mg doses were recruited. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The patient's dose was the same for the entire study.
The order of Methotrexate (MTX) treatment arms (A-SC injection with Vibex-MTX device, B-SC injection without device and C-IM Injection) were randomly assigned and dosing was separated by interval of atleast 7 days to allow for washout before the next treatment was administered.
Participant milestones
| Measure |
10mg MTX Group
\[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection\]
|
15mg MTX Group
\[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection\]
|
20mg MTX Group
\[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection\]
|
25mg MTX Group
\[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection\]
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Baseline characteristics by cohort
| Measure |
10mg MTX Group
n=9 Participants
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
|
15mg MTX Group
n=9 Participants
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
|
20mg MTX Group
n=9 Participants
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
|
25mg MTX Group
n=9 Participants
\[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C\]
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 7.26 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 6.18 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 6.80 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 7.76 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Outcome measures
| Measure |
Treatment Arm A
n=36 Participants
Subcutaneous (SC) injection with the Vibex MTX device
|
Treatment Arm B
n=36 Participants
SC injection of MTX without the device
|
Treatment Arm C
n=36 Participants
Intramuscular (IM) injection of MTX
|
|---|---|---|---|
|
Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
|
118.14 ng*hr/mL/mg
Standard Deviation 42.300 • Interval 55.65 to 213.94
|
122.63 ng*hr/mL/mg
Standard Deviation 40.648 • Interval 80.0 to 125.0
|
116.71 ng*hr/mL/mg
Standard Deviation 41.394 • Interval 80.0 to 125.0
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison
Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC\[0-24\]/Dose) for each treatment
Outcome measures
| Measure |
Treatment Arm A
n=36 Participants
Subcutaneous (SC) injection with the Vibex MTX device
|
Treatment Arm B
n=36 Participants
SC injection of MTX without the device
|
Treatment Arm C
n=36 Participants
Intramuscular (IM) injection of MTX
|
|---|---|---|---|
|
Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX
|
116.60 ng*hr/mL/mg
Standard Deviation 40.963
|
121.08 ng*hr/mL/mg
Standard Deviation 39.405
|
122.63 ng*hr/mL/mg
Standard Deviation 40.648
|
PRIMARY outcome
Timeframe: 24 Hour periodPopulation: The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.
Dose-normalized maximum observed concentration for each treatment
Outcome measures
| Measure |
Treatment Arm A
n=36 Participants
Subcutaneous (SC) injection with the Vibex MTX device
|
Treatment Arm B
n=36 Participants
SC injection of MTX without the device
|
Treatment Arm C
n=36 Participants
Intramuscular (IM) injection of MTX
|
|---|---|---|---|
|
Bioequivalence Based Upon Dose-Normalized Cmax for MTX
|
21.43 ng/mL/mg
Standard Deviation 8.310
|
22.38 ng/mL/mg
Standard Deviation 10.263
|
23.37 ng/mL/mg
Standard Deviation 7.188
|
Adverse Events
10mg MTX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
15mg MTX
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20mg MTX
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25mg MTX
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 |
10mg MTX
n=9 participants at risk
\[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C\]
|
15mg MTX
n=9 participants at risk
\[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C\]
|
20mg MTX
n=9 participants at risk
\[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C\]
|
25mg MTX
n=9 participants at risk
\[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C\]
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
11.1%
1/9 • Number of events 2 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
11.1%
1/9 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
11.1%
1/9 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
11.1%
1/9 • Number of events 1 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
0.00%
0/9 • The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 36 subjects.
Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.
|
Additional Information
Jonathan Jaffe, MD; Vice President Clinical Development
Antares Pharma
Phone: 1-609-359-3020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60