A Study to Assess the Effect of Particle Size of AZD7594 on Pharmacokinetics (PK) After a Single Inhaled Dose When Administered Using the Dry Powder Inhaler in Healthy Volunteers
Condition: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, randomized, three-way crossover study to assess the effect of
      particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects
      (males aged 18 to 55 years [inclusive]). The study will be performed at a single study
      center.
    

Detailed description: 
      The study will comprise:

        -  A Screening period of maximum 28 days.

        -  Three treatment periods during which subjects will be resident prior to the evening meal
           the 1 day before dosing with AZD7594 (Day -1) until at least 48 hours after dosing;
           discharged on the morning of Day 3. Subjects will then return for ambulatory visits 72,
           96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).

        -  A final Follow-up Visit within 10 days after the last administration of AZD7594. This
           visit will coincide with the last PK sample collection on Day 11 after the last
           Treatment Period.

      There will be a minimum wash-out period of 21 and maximum of 28 days between each dose
      administration.

      Subjects will attend a Screening Visit within 28 days before receiving their first dose of
      AZD7594, if they are found to be eligible, they return for Treatment Period 1, when they will
      have baseline assessments, and then will be randomized into one of the 6 treatments
      sequences. For each Treatment Period, the subjects will receive their investigational
      medicinal product (IMP) dose in the morning of Day 1, will have further assessments for 48
      hours after dosing (residential period) and will return to the study center for ambulatory
      visits 72, 96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).

      Each subject will receive AZD7594 as a single inhaled dose of 440 µg (nominal dose) of each
      of the following treatments, administered via Dry powder inhaler (DPI):

        -  Treatment A: Particle size Large

        -  Treatment B: Particle size Medium

        -  Treatment C: Particle size Small Each subject will be involved in the study for up to 12
           weeks (up to 4 weeks for enrollment and 8 weeks of active study and Follow-up).
    

Intervention name(s): Treatment A - AZD7594; Treatment B - AZD7594; Treatment C - AZD7594
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Particle size Large as a single inhaled dose of 440 µg (nominal dose), administered via DPI; Particle size Medium as a single inhaled dose of 440 µg (nominal dose), administered via DPI; Particle size Small as a single inhaled dose of 440 µg (nominal dose), administered via DPI
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Chronic obstructive pulmonary disease (COPD); Healthy volunteers; Pharmacokinetics (PK); Bioavailability; AZD7594; Safety; Tolerability