An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      In the current study GSK961081 and fluticasone propionate will be administered in a blended
      formulation from a single device and compared with GSK961081 and fluticasone propionate
      administered alone and concurrently. This is a single centre, randomized, double-blind,
      double dummy, single dose, four way cross-over study investigating the pharmacokinetics and
      pharmacodynamics of GSK961081 and fluticasone propionate when administered alone,
      concurrently and as a combination blend in healthy subjects.
    

Detailed description: 
      This will be the first time that GSK961081 and fluticasone propionate will be administered as
      a blend in humans. In previous clinical studies conducted in Chronic Obstructive Pulmonary
      Disease (COPD) patients, GSK961081 has been administered on a background of fluticasone
      propionate without any observed systemic pharmacodynamic interaction. In this study GSK961081
      and fluticasone propionate will be administered in a blended formulation from a single device
      and compared with GSK961081 and fluticasone propionate administered alone and concurrently.
      The aim of the study will be to investigate any differences in pharmacodynamics and/or
      pharmacokinetics for GSK961081 and fluticasone propionate when administered as the blend,
      concurrently or alone.

      Pharmacokinetic, pharmacodynamic and safety information will be gathered to assess the
      suitability of the GSK9610981/fluticasone propionate blend for further development.Each
      subject will receive four treatments (GSK961081 alone, fluticasone propionate alone,
      GSK961081 and fluticasone propionate concurrently, and GSK961081/fluticasone propionate
      blend) in randomized order, in four treatment periods, each separated by a washout period of
      at least a week. All treatments will be administered via a DISKUS inhaler.

      Pharmacokinetics, pharmacodynamics and safety will be assessed by measurement of plasma
      GSK961081, plasma fluticasone propionate, serum cortisol, urine cortisol, blood glucose,
      serum potassium, Forced Expiratory Volume in one second (FEV1), heart rate, 12-lead
      Electrocardiograms (ECGs), clinical laboratory tests and collection of adverse events (AEs).
    

Intervention name(s): GSK961081 800 microgram dose; Fluticasone Propionate 500 microgram dose; GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately; GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): To be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers; To be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers; To be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation; To be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment