A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants
Condition: Chronic Obstructive Pulmonary Disease (COPD); Asthma
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor
      (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary
      disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist
      with the potential for once daily treatment of asthma and COPD in fixed dose combination
      (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first
      clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC
      or in free combination via 2 separate dry powder inhalers (DPIs). This study will be
      conducted in healthy male subjects to minimize the effects of concomitant disease states or
      medications on study measurements.
    

Detailed description: 
      AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor
      (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary
      disease (COPD) and asthma. Inhaled corticosteroids (ICS) have not been definitively shown to
      decrease the rate of decline in lung function that is typical of COPD. The aim is to develop
      AZD7594 as a well tolerated once daily selective inhaled GR modulator with an acceptable side
      effect profile compared to conventional ICS on the market. Abediterol is a novel and
      selective β2 adrenergic receptor agonist with the potential for once daily treatment of
      asthma and COPD in fixed dose combination (FDC) with an ICS or a novel anti inflammatory (AI)
      agent Fixed dose ICS/LABA combination treatment is more effective in improving lung function,
      health status and reducing exacerbations than the individual components. The long term goal
      of abediterol development program in COPD is to investigate it both as a monotherapy and as a
      combination therapy in conjunction with an ICS or a novel anti inflammatory agent. This study
      will be the first clinical study for the combination exposure of AZD7594 with abediterol as 2
      compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This study
      will be conducted in healthy male subjects to minimize the effects of concomitant disease
      states or medications on study measurements. Subjects will receive all 4 treatments in a
      randomized order. Given that the treatment in each period is a single dose of AZD7594, a 21
      (±2) day wash out should be adequate to prevent carry over effect to next period. The
      abediterol elimination half life is shorter than that of AZD7594. Therefore, a 21 (±2) day
      wash out is sufficient for the elimination of both AZD7594 and abediterol. Overall,
      pre-clinical and clinical data generated to date with abediterol show expected safety
      profile, and support the continued studies with abediterol.
    

Intervention name(s): Abediterol; AZD7594; AZD7594/abediterol; AZD7594 and abediterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: Abediterol 2.5 μg via DPI; Treatment B: AZD7594 440 μg via DPI; Treatment C: AZD7594/abediterol 440 μg/2.5 μg FDC via DPI; Treatment D: AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs
Other intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease (COPD); asthma