Healthy SubjectsPhase 1NCT01365611

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

A Phase 1 study testing Ketorolac tromethamine and Fluticasone Propionate in people with Healthy Subjects, run by Egalet Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Ketorolac tromethamine and Fluticasone Propionate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2007to Mar 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female volunteers aged 18 to 60 years inclusive
Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breastfeeding
All male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, intrauterine device or surgical sterilization plus condom or diaphragm with spermicidal agent) throughout the study period
Subject must have given signed informed consent
Subject was within 20% of the normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
Subject's medical history was considered normal, with no clinically significant abnormalities

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Subject was considered to be in good health in the opinion of the Investigator as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
Subject's pre study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
Subject had a body weight of at least 60 kg

Who cannot join

Subject had had a clinically significant illness in the 4 weeks before screening
Subject had used prescribed medications in the 3 weeks prior to dosing or over-the-counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 h prior to dosing. However, use of multivitamins and oral contraceptives was permitted
Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening
Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
Subject was a current user of tobacco or had a history of smoking in the past 5 years
Subject was in the opinion of the Investigator not suitable to participate in the study

Show all 20Show fewer

Subject had participated in any clinical study with an investigational drug/device within 3 months prior to dosing
Subject had a positive result of human immunodeficiency virus (HIV) screen, hepatitis B screen or hepatitis C screen
Subject had had a serious adverse reaction or significant hypersensitivity to any drug
Subject had donated 500 mL or more of blood within the 3 months prior to screening
Subject had any history of co-existing nasal polyps, nonsteroidal anti-inflammatory drug (NSAID) sensitivity and asthma
Subject had had an allergic reaction to aspirin or other NSAIDs
Subject had a current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs)
Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
Subject had used a monoamine oxidase inhibitor in the 14 days prior to study entry
Subject had active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
Subject had anemia due to unexplained or known gastrointestinal bleeding
Subject had a history of asthma or any other chronic pulmonary disorder
Subject had renal impairment or a risk of renal failure due to volume depletion
Subject had a previous history of nasal surgery

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

ICON Development Solutions
Manchester

Other trials in United Kingdom

About this study

Official title: Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Multiple Doses of Fluticasone Propionate in Healthy Subjects

This was a non-randomized, open label study in healthy male and female volunteers. A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7, and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study medical was performed within 7 days of study completion.

The objective of this study was to assess the effects of chronic administration of fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and female subjects.

Conditions: Healthy Subjects
Being tested: Ketorolac tromethamine, Fluticasone Propionate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketorolac tromethamineDrug
A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
Fluticasone PropionateDrug
Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6

Study groups in NCT01365611
Study group	Role	What they receive
Ketorolac tromethamine	Experimental	Not described Receives: Drug: Ketorolac tromethamine; Drug: Fluticasone Propionate

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)
Measured: 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
Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)
Measured: 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
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).
Measured: 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
AUC Inf (the AUC From Time Zero to Infinity, Where Possible)
Measured: 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
t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)
Measured: 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
MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Mar 2008

First posted3 Jun 2011 (estimated)
Study startFeb 2007
Primary completionMay 2007
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365611
Sponsor's protocol ID: ROX 2006-04
Status last verified: Feb 2017
First submitted: 1 Jun 2011
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Multiple Doses of Fluticasone Propionate in Healthy Subjects
ClinicalTrials.gov ID: NCT01365611
Acronym / sponsor ID: ROX 2006-04
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Egalet LtdIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: May 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 30 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study was to assess the effects of chronic administration of fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and female subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ketorolac tromethamine	Experimental	Drug: Ketorolac tromethamine, Drug: Fluticasone Propionate

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male or female volunteers aged 18 to 60 years inclusive
Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breastfeeding
All male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, intrauterine device or surgical sterilization plus condom or diaphragm with spermicidal agent) throughout the study period
Subject must have given signed informed consent
Subject was within 20% of the normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)

Key exclusion criteria (20 listed)

Subject had had a clinically significant illness in the 4 weeks before screening
Subject had used prescribed medications in the 3 weeks prior to dosing or over-the-counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 h prior to dosing. However, use of multivitamins and oral contraceptives was permitted
Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening
Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
Subject was a current user of tobacco or had a history of smoking in the past 5 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketorolac tromethamineA single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.	Drug	Ketorolac tromethamine
Fluticasone PropionateDaily intranasal dose of 200 ug fluticasone propionate on Days 2-6	Drug	Ketorolac tromethamine

Primary outcome

Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)
Time frame: 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
Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)
Time frame: 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
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).
Time frame: 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
AUC Inf (the AUC From Time Zero to Infinity, Where Possible)
Time frame: 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
t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)
Time frame: 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
MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)
Time frame: 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 and safety

Results posted to the registry on 30 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	36	36

Primary outcome: Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)

Time frame: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Ketorolac Tromethamine (Given Alone) n = 36	Fluticasone Propionate + Ketorolac Tromethamine n = 36
Value	2128 (1042.5)	1948 (1018.3)

Primary outcome: Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)

Measure	Ketorolac Tromethamine (Given Alone) n = 36	Fluticasone Propionate + Ketorolac Tromethamine n = 36
Value	0.750 (0.25 to 1.00)	0.750 (0.25 to 1.00)

Primary outcome: 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).

Measure	Ketorolac Tromethamine (Given Alone) n = 36	Fluticasone Propionate + Ketorolac Tromethamine n = 36
Value	7991 (4364.2)	7610 (4076.8)

Primary outcome: AUC Inf (the AUC From Time Zero to Infinity, Where Possible)

Measure	Ketorolac Tromethamine (Given Alone) n = 35	Fluticasone Propionate + Ketorolac Tromethamine n = 36
Value	8970 (4575)	8276 (4380.7)

Population analysed: The half-life could not be estimated for a subject due to the nature of the subject's PK profile.

Adverse events

Time frame: 3 months and 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketorolac Tromethamine (Given Alone)	0 of 36 (0%)	8 of 36 (22.2%)	Not reported
Fluticasone Propionate + Ketorolac Tromethamine	0 of 36 (0%)	7 of 36 (19.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cyril Clarke, BSc MB BS MFPM principal investigator

ICON Development Solutions

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ketorolac tromethamine and Fluticasone Propionate in people with Healthy Subjects, run by Egalet Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine) (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01365611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.