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CompletedNCT01299558Updated Jun 12, 2017

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 interventional study of fluticasone furoate//GW642444 and fluticasone furoate in Asthma, sponsored by GlaxoSmithKline. Completed at 1 site in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Asthma

Keywords

  • pharmacokinetics
  • GW642444
  • absolute bioavailability
  • healthy subjects
  • fluticasone furoate
  • GW685698
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In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Other
    Treatment period 1

    Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1

    Drug: fluticasone furoate//GW642444

  • Other
    Treatment Period 2

    Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2

    Drug: fluticasone furoate

  • Other
    Treatment Period 3

    Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3

    Drug: GW642444

Interventions

  • Drugfluticasone furoate//GW642444

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

  • Drugfluticasone furoate

    Single IV dose of FF (250mcg)

  • DrugGW642444

    Single IV dose of GW642444 (55mcg)

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What researchers measure

Primary outcomes

  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

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Approximately 9 weeks for each subject

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

    Time frame: Approximately 9 weeks for each subject

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Study locations

1 site
  • GSK Investigational Site
    Randwick, New South Wales 2031, Australia
08

References and documents

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01299558
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 18, 2011
Start date
May 17, 2010
Primary completion
Jul 15, 2010
Completion
Jul 15, 2010
Last update
Jun 12, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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