QTc Study GSK573719+GW642444
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo controlled, four period incomplete block,crossover thorough QT
      study to estimate the effect of repeat dose GSK573719/GW642444M (Vilanterol) combination and
      GSK573719 monotherapy on the QTc interval in healthy male and female subjects compared with
      placebo. At least 100 subjects will receive, four of five possible, 10-day repeat dose
      treatments. Treatments are placebo with a moxifloxacin placebo on day 10, placebo with
      moxifloxacin (400mg) on day 10, GSK573719/Vilanterol combination (125/25μg) with moxifloxacin
      placebo on day 10, GSK573719/Vilanterol combinatio (500/100μg) with moxifloxacin placebo on
      day 10, or GSK573719 (500μg) with a moxifloxacin placebo on day 10. All treatments are double
      blind except for moxifloxacin (400mg) and moxifloxacin placebo controls, given as a
      single-blind single dose on Day 10 of the appropriate treatment period.

      Primary endpoints are individual time-matched changes from baseline QTcF for
      GSK573719/Vilanterol combination (125/25μg) and GSK573719 (500μg), 0-24 hours after dosing on
      Day 10. Secondary endpoints will include individual time-matched changes from baseline in
      QTcF for GSK573719/Vilanterol combination (500/100μg) and moxifloxacin (400mcg) 0-24 hours
      after dosing on Day 10. Also changes from baseline in QTci, QTcB, QT, QRS, RR, PR and
      ventricular rate at each time point after 10 days dosing of each GSK573719 and
      GSK573719/Vilanterol treatment and single dose moxifloxacin (400mg). Maximal change from
      baseline 0-24hours after dosing on day 10 will be derived for QTcF, QTci and QTcB for each
      treatment. Plasma concentrations on Day 10 (0-24 hours) and pharmacokinetic parameters of
      GSK573719 and Vilanterol will also be derived. Key assessments: 12- lead electrocardiogram
      (ECG), pharmacokinetics. Safety will be assessed by blood pressure, heart rate, clinical
      laboratory safety tests and collection of adverse events (AEs).
    


Intervention name(s): Placebo Moxifloxacin; Moxifloxacin; GSK573719/Vilanterol 125/25mcg; GSK573719; GSK573719/Vilanterol 500/100mcg; Placebo DPI
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose placebo oral tablet Moxifloxacin; Single oral dose tablet Moxifloxacin (400mg); Single inhalation from GSK573719/Vilanterol 125/25mcg DPI once daily; Single inhalation from GSK573719 500mcg DPI once daily; Single inhalation from GSK573719/Vilanterol 500/100mcg DPI once daily; Single Inhalation from matching Placebo DPI once daily
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LAMA; Respiratory; COPD; Tolerability; Beta-2 Agonist; Safety; Pharmacokinetics; Pharmacodynamics; LABA; Muscarinic Receptor Agonist; Healthy subjects; Moxifloxacin; Anticholinergic; GW642444; GSK573719; QTc