Trial Outcomes & Findings for Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects (NCT NCT01365611)
NCT ID: NCT01365611
Last Updated: 2017-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6
Results posted on
2017-03-15
Participant Flow
February 7, 2007 - May 22, 2007; Clinical Unit
Participant milestones
| Measure |
All Study Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|
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Overall Study
STARTED
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36
|
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Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Study Participants
n=36 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|
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Age, Categorical
<=18 years
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1 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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35 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
|
33.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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26 Participants
n=5 Participants
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Region of Enrollment
United Kingdom
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36 participants
n=5 Participants
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=36 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)
|
2128 ng/mL
Standard Deviation 1042.5
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1948 ng/mL
Standard Deviation 1018.3
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=36 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)
|
0.750 hours
Interval 0.25 to 1.0
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0.750 hours
Interval 0.25 to 1.0
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=36 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).
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7991 ng*hours/mL
Standard Deviation 4364.2
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7610 ng*hours/mL
Standard Deviation 4076.8
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Population: The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=35 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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AUC Inf (the AUC From Time Zero to Infinity, Where Possible)
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8970 ng*hours/mL
Standard Deviation 4575
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8276 ng*hours/mL
Standard Deviation 4380.7
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Population: The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=35 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)
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5.95 hours
Standard Deviation 2.105
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5.49 hours
Standard Deviation 2.004
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PRIMARY outcome
Timeframe: PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6Population: The half-life could not be estimated for a subject due to the nature of the subject's PK profile.
Outcome measures
| Measure |
Ketorolac Tromethamine (Given Alone)
n=35 Participants
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 Participants
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)
|
7.05 hours
Standard Deviation 2.141
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6.53 hours
Standard Deviation 2.354
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Adverse Events
Ketorolac Tromethamine (Given Alone)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Fluticasone Propionate + Ketorolac Tromethamine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketorolac Tromethamine (Given Alone)
n=36 participants at risk
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
|
Fluticasone Propionate + Ketorolac Tromethamine
n=36 participants at risk
Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
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|---|---|---|
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General disorders
Fatigue
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2.8%
1/36 • Number of events 1 • 3 months and 2 weeks
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5.6%
2/36 • Number of events 2 • 3 months and 2 weeks
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Nervous system disorders
Headache
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11.1%
4/36 • Number of events 5 • 3 months and 2 weeks
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2.8%
1/36 • Number of events 1 • 3 months and 2 weeks
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Nervous system disorders
Somnolence
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2.8%
1/36 • Number of events 1 • 3 months and 2 weeks
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11.1%
4/36 • Number of events 4 • 3 months and 2 weeks
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Respiratory, thoracic and mediastinal disorders
Sneezing
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5.6%
2/36 • Number of events 2 • 3 months and 2 weeks
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0.00%
0/36 • 3 months and 2 weeks
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Additional Information
David Bregman, M.D., Ph.D.
Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place