In this study, fluticasone furoate (FF) and vilanterol (VI) in different dose combinations (50/25mcg, 100/25mcg and 200/25mcg) will be administered from a single dry powder device to evaluate the PD, PK, safety and tolerability of the combination in healthy Chinese subjects. The information gathered will be used as a support of the clinical development program of the fixed dose combination of FF/VI inhalation powder in Chinese population.
This is a single centre, double-blind, placebo-controlled, four-way cross over, randomized, single and repeat dose study. A total of 16 healthy subjects aged 18-45 years will be randomised with the aim of achieving at least 10 evaluable subjects to each treatment period. The primary objective is to evaluate the systemic steroid PD effects (serum cortisol 24 hour weighted mean on Day 7) of FF and systemic ß-adrenergic PD effects (ECG maximum QTcF 0-4h and whole blood potassium 0-4h in Day 1 and Day 7) of VI; the secondary objectives are aimed to evaluate the PK, safety and tolerability of FF/VI inhalation powder after a single and repeat dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
50/25 or 100/25 or 200/25 mcg inhaled once daily for 7 days in each treatment period.
Placebo inhaled once daily for 7 days in each treatment period.
GSK Investigational Site
Beijing, China
Systemic steroid PD effects
Serum cortisol
Time frame: Day 7
Systemic ß-adrenergic PD effects
Maximum QTcF 0-4h and whole blood potassium
Time frame: Day 1 and Day 7
Plasma concentrations and derived PK parameters for FF/VI
Single dose: Cmax, tmax, t1/2, AUC(0-t) (AUC from zero to the last quantifiable timepoint) and AUC(0-t') (AUC from zero to the last common quantifiable timepoint in the dose group). Repeat dose: FF: Cmax, tmax, t1/2, AUC(0-t) and AUC(0-t'), Ro and RCmax, Css\_min and AUCss , Css\_av, DF; VI: Cmax, tmax, t1/2, AUC(0-t) and AUC(0-t')
Time frame: Pre-dose, 5 min, 15 min, 30 min, 1h, 1.5h, 2h, 4h post dose on Day 1 and pre-dose, 5 min, 15 min, 30 min, 1h, 1.5h, 2h, 4h, 6h, 8h, 12h and 24h post dose on Day 7 and 8.
Vital signs
blood pressure and heart rate
Time frame: Screening Visit, Day 1, Day 7 and Follow-up Visit
12-lead ECG
12-lead ECG
Time frame: Screening Visit, Day 1, Day 7 and Follow-up Visit
Laboratory tests
Clinical chemistry, hematology and urinalysis
Time frame: Screening Visit, Day 8 of treatment period 4 or early withdrawal Visit and/or follow-up Visit
Adverse events
adverse events
Time frame: From the start of dosing with investigational product and until the follow-up visit.
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