Rhinitis, Allergic, Perennial and SeasonalPhase 1NCT01962467

A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine

A Phase 1 study testing FF/LEV FDC, FF and LEV in people with Rhinitis, Allergic, Perennial and Seasonal, run by GlaxoSmithKline at 1 site in Australia.

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 65 yearsHealthy volunteers can take part
Conditions the study is for: Rhinitis, Allergic, Perennial and Seasonal
What is being tested?: FF/LEV FDC, FF and LEV
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteAustralia
Study dates: 11 Oct 2013to 27 Feb 2014
Phase: Phase 1
Are there results?: None posted in the registry

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male/Females aged between 18, 20 for Korean subjects, and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Caucasian, defined as having four grandparents who were descendents of European Caucasians, or Korean origin defined as being born in mainland Korea, having four ethnic Korean grandparents, holding a Korean passport or identity papers and being able to speak Korean. Korean subjects should also have lived outside their respective countries for less than 10 years.
Body weight >=50 kilogram (kg), >=45 kg for Korean subjects, and body mass index (BMI) within the range 18 - 30 Kilogram per meter square (kg/m^2) (inclusive).
A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units per milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<147 picomole/liter) is confirmatory]; child-bearing potential with negative pregnancy test as determined by urine Human Chorionic Gonadotropin (hCG) test at screening or prior to dosing AND agrees to use one of the contraception methods as described for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 8 days post-last dose.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x Upper Limit of Normal (ULN) [isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%].
Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QT interval corrected for heart rate using Fridericia'sformulas (QTcF) <450 milliseconds (msec).

Who cannot join

Criteria Based Upon Medical Histories:
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of regular alcohol consumption within 6 months of the study defined as: For Australian (AUST) sites: An average weekly intake of >21 units for males or > 14 units for females. In Australia one unit (=standard drink) is equivalent to 10 grams (g) of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%).
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
Nasal abnormalities likely to affect the outcome of the study, i.e., nasal septal perforation, nasal polyps, other nasal malformations.
History of frequent nosebleeds.

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Subjects should be non-smokers, which for this study is defined as having smoked < 10 pack years in their lifetime, and have not smoked in the 6 months prior to the screening visit.
Criteria Based Upon Diagnostic Assessments
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus (HIV) antibody.
Urine cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Other Criteria:
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Lactating females.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Any history of nasal surgery which may affect the outcome of the study (i.e., turbinectomy, major nasal reconstruction, septal perforation repair).
Any history in the past 5 years of either perennial or seasonal allergic rhinitis, or any subject expected to have symptoms of allergic rhinitis during the study.
Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms associated with the URTI have been completely resolved for more than 3 weeks prior to screening

Trial locations and contacts

1 site in 1 country.

Australia1 site

GSK Investigational Site
Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: A Relative Bioavailability Study to Compare the Pharmacokinetics of a Fixed Dose Combination of Fluticasone Furoate and Levocabastine With Levocabastine and Fluticasone Furoate Alone

This is an open label, randomized, 3-way cross-over, and repeat administration study in healthy male and female subjects. The purpose of the study is to determine the relative bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18 subjects will be enrolled). Each part will consist of three treatment periods separated by a minimum washout period of 14 days. In each treatment period, subjects will receive seven daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray according to one of the 6 possible randomization sequences. The study will use an adaptive design with an interim review following Part A to confirm whether Part B is required.

Conditions: Rhinitis, Allergic, Perennial and Seasonal
Being tested: FF/LEV FDC, FF, LEV
Keywords: Allergic rhinitis, healthy volunteers, fluticasone furoate, levocabastine, fixed dose combination, pharmacokinetics
Medical subject headings: Rhinitis, Rhinitis, Allergic

What participants receive

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

FF/LEV FDCDrug
Intranasal aqueous microsuspension containing 25.0 microgram (µg) of FF and 50 µg of LEV as a fixed dose combination. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
FFDrug
Intranasal aqueous microsuspension containing 27.5µg of FF. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
LEVDrug
Intranasal aqueous microsuspension containing 50 µg of LEV. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state

Study groups in NCT01962467
Study group	Role	What they receive
Arm 1	Experimental	Each subject will receive 7 once daily doses of one of the 3 treatments (FF/LEV FDC or FF or LEV) administered as two 50 µL sprays per nostril in the morning, during each of the 3 treatment periods, as per one of the 6 possible randomization sequences. Each treatment period will be separated by a minimum washout period of 14 days Receives: Drug: FF/LEV FDC; Drug: FF; Drug: LEV

What is being measured

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

Plasma concentrations of FF and LEV
Concentrations of FF and LEV will be determined in plasma samples
Measured: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period
Pharmacokinetic (PK) parameters for both FF and LEV
From the plasma concentration-time data, area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of FF and LEV were determined
Measured: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period

Secondary outcomes (2)

PK parameters for both FF and LEV alone and in combination
From the plasma concentration-time data, AUC, Cmax and time to maximum observed plasma drug concentration (tmax) of FF and LEV alone and in combination were determined for healthy Korean male and female subjects
Measured: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period
tmax
Tmax of FF and LEV alone and in combination were determined for healthy male and female subjects
Measured: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period

Timeline

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

11 Oct 201327 Feb 2014

First posted14 Oct 2013 (estimated)
Study start11 Oct 2013
Primary completion27 Feb 2014
Study completion27 Feb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rhinitis, Allergic, Perennial and SeasonalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01962467
Sponsor's protocol ID: 200284
Status last verified: May 2017
First submitted: 10 Oct 2013
Last updated: 15 May 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Relative Bioavailability Study to Compare the Pharmacokinetics of a Fixed Dose Combination of Fluticasone Furoate and Levocabastine With Levocabastine and Fluticasone Furoate Alone
ClinicalTrials.gov ID: NCT01962467
Acronym / sponsor ID: 200284
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: Allergic rhinitis, healthy volunteers, fluticasone furoate, levocabastine, fixed dose combination, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Oct 2013 (actual)
Primary completion: 27 Feb 2014 (actual)
Study completion: 27 Feb 2014 (actual)
First posted: 14 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Drug: FF/LEV FDC, Drug: FF, Drug: LEVEach subject will receive 7 once daily doses of one of the 3 treatments (FF/LEV FDC or FF or LEV) administered as two 50 µL sprays per nostril in the morning, during each of the 3 treatment periods, as per one of the 6 possible randomization sequences. Each treatment period will be separated by a minimum washout period of 14 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male/Females aged between 18, 20 for Korean subjects, and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Caucasian, defined as having four grandparents who were descendents of European Caucasians, or Korean origin defined as being born in mainland Korea, having four ethnic Korean grandparents, holding a Korean passport or identity papers and being able to speak Korean. Korean subjects should also have lived outside their respective countries for less than 10 years.
Body weight >=50 kilogram (kg), >=45 kg for Korean subjects, and body mass index (BMI) within the range 18 - 30 Kilogram per meter square (kg/m^2) (inclusive).
A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units per milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<147 picomole/liter) is confirmatory]; child-bearing potential with negative pregnancy test as determined by urine Human Chorionic Gonadotropin (hCG) test at screening or prior to dosing AND agrees to use one of the contraception methods as described for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 8 days post-last dose.

Key exclusion criteria (21 listed)

Criteria Based Upon Medical Histories:
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of regular alcohol consumption within 6 months of the study defined as: For Australian (AUST) sites: An average weekly intake of >21 units for males or > 14 units for females. In Australia one unit (=standard drink) is equivalent to 10 grams (g) of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%).
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
Nasal abnormalities likely to affect the outcome of the study, i.e., nasal septal perforation, nasal polyps, other nasal malformations.

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
FF/LEV FDCIntranasal aqueous microsuspension containing 25.0 microgram (µg) of FF and 50 µg of LEV as a fixed dose combination. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state	Drug	Arm 1
FFIntranasal aqueous microsuspension containing 27.5µg of FF. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state	Drug	Arm 1
LEVIntranasal aqueous microsuspension containing 50 µg of LEV. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state	Drug	Arm 1

Primary outcome

Plasma concentrations of FF and LEV
Time frame: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period
Concentrations of FF and LEV will be determined in plasma samples
Pharmacokinetic (PK) parameters for both FF and LEV
Time frame: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period
From the plasma concentration-time data, area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of FF and LEV were determined

2 secondary outcomes

PK parameters for both FF and LEV alone and in combination
Time frame: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period
tmax
Time frame: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Results for study 200284 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

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 FF/LEV FDC, FF and LEV in people with Rhinitis, Allergic, Perennial and Seasonal, run by GlaxoSmithKline at 1 site in Australia.

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 8 inclusion and 21 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 May 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 Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Plasma concentrations of FF and LEV (time frame: Day 7 (Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose) and Day 8 (24 hours post-dose) of each treatment period). The study lists 2 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 NCT01962467.

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 May 2017.