GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and
      beta2-agonism in a single molecule and is in development for the treatment of chronic
      obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled
      corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting
      beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in
      combination with BAT, for treatment of COPD.

      This study is an open-label, six-way crossover, single and repeat dose study to evaluate the
      systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the
      ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a
      single dose, and at the proposed clinical dose, following repeat doses.

      This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each
      subject will have 3 periods in which they receive a single dose treatment regimen (3
      inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a
      single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of
      those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8,
      subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a
      minimum of 7-day washout between each treatment periods. All subjects will receive 9
      treatments and follow-up procedures will be done 7 14 days after the last dose.

      Forty eight healthy subjects will be enrolled into the study, such that approximately 40
      subjects complete dosing and PK assessments. The total duration of participation for each
      subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the
      GlaxoSmithKline [GSK] group of companies.
    


Intervention name(s): BAT/FF; BAT; FF; FF (MgSt); FF/Vilanterol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BAT/FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose and its physical appearance is dry white powder. Second strip contains 100 mcg per blister of FF blended with lactose and its physical appearance is dry white powder.; BAT is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose appear as dry white powder. Second strip contains lactose which appear as a dry white powder.; FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose which appear as dry white powder.; FF magnesium stearate is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose with magnesium stearate which appear as dry white powder.; FF/Vilanterol is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 25 mcg per blister of vilanterol blended with lactose and magnesium stearate appear as dry white powder and second strip contains 100 mcg per blister of FF blended with lactose which appear as dry white powder.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluticasone furoate; Chronic obstructive pulmonary disease; Batefenterol; Dry Powder Inhaler; Respiratory; Pharmacokinetics; Ellipta; Healthy Subjects