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
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%).
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.
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.
Exclusion Criteria:
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
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
Drug: fluticasone furoate
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
Drug: GW642444
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
Single IV dose of FF (250mcg)
Single IV dose of GW642444 (55mcg)
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
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
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
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
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 9 weeks for each subject
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.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline