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AsthmaPhase 1NCT01299558

Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects

A Phase 1 study testing fluticasone furoate//GW642444, fluticasone furoate and GW642444 in people with Asthma, 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

This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects. Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
fluticasone furoate//GW642444, fluticasone furoate and GW642444
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteAustralia
Study dates
17 May 2010to 15 Jul 2010
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female between 18 and 64 years of age inclusive
  • Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
  • Subjects who are current non-smokers
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
  • No significant abnormality on the Holter ECG at screening
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  • FEV1 ≥ 85% predicted at screening.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Subjects who are able to use the inhalation device satisfactorily

Who cannot join

  • As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
  • Any history of breathing problems in adult life
  • Pregnant or lactating females
  • The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
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  • Subjects with recent history (within 6 months) of pneumonia
  • 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 GSK Medical Monitor, contraindicates their participation
  • Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
  • History of milk protein allergy
  • 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
  • The subject has taken oral corticosteroids less than 8 weeks before the screening visit
  • The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
  • History of alcohol/drug abuse or dependence within 12 months of the study
  • 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
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • The subject has tested positive for HIV antibodies
  • A positive pre-study urine drug screen or when randomly tested during the study
  • Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
  • Positive urine cotinine test at screening
  • Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication
  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Subject is mentally or legally incapacitated

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: An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects

This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects. Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).

Read the detailed description

Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting, beta2-receptor agonist (LABA), are currently under development in combination for use as a once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD). FF is also being developed as a stand-alone product for asthma and GW642444 is also being developed as a stand-alone product and in combination with a novel, long-acting muscarinic antagonist for the treatment of COPD. This study is being performed to determine the absolute bioavailability of both FF and GW642444 when delivered in combination from the novel dry powder inhaler.

Conditions
Asthma
Being tested
fluticasone furoate//GW642444, fluticasone furoate, GW642444
Keywords
pharmacokinetics, GW642444, absolute bioavailability, healthy subjects, fluticasone furoate, GW685698
Medical subject headings
Asthma

What participants receive

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

  • fluticasone furoate//GW642444Drug

    Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning

  • fluticasone furoateDrug

    Single IV dose of FF (250mcg)

  • GW642444Drug

    Single IV dose of GW642444 (55mcg)

Study groups in NCT01299558
Study groupRoleWhat they receive
Treatment period 1OtherSingle inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1
Receives: Drug: fluticasone furoate//GW642444
Treatment Period 2OtherSingle IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
Receives: Drug: fluticasone furoate
Treatment Period 3OtherSingle IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
Receives: Drug: GW642444

What is being measured

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

  1. Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously

    Measured: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks

Secondary outcomes (5)

  1. Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments

    Measured: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks

  2. Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability

    Measured: Approximately 9 weeks for each subject

  3. Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability

    Measured: Approximately 9 weeks for each subject

  4. Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability

    Measured: Approximately 9 weeks for each subject

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Approximately 9 weeks for each subject

Timeline

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

  1. First posted18 Feb 2011 (estimated)
  2. Study start17 May 2010
  3. Primary completion15 Jul 2010
  4. Study completion15 Jul 2010

Resources

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
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01299558
Sponsor's protocol ID
102934
Status last verified
Jun 2017
First submitted
10 Jun 2010
Last updated
12 Jun 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fluticasone furoate//GW642444, fluticasone furoate and GW642444 in people with Asthma, 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 9 inclusion and 25 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 12 Jun 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?

Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously (time frame: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks). 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 NCT01299558.

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 12 Jun 2017.

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