The purpose of this study is to evaluate the potential difference between pharmacokinetics (PK), safety, tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation.
This is a randomized, open-label, 2- treatment, 2- period study with a duration of approximately 6 weeks. The Study will comprise of: * A Screening period of 28 days, * Treatment Period 1 on Day 1 and Treatment Period 2 on Day 9 * A Follow-up visit within 7 days (± 2 days) after the last dose in Period 2. Participants will be randomized 1:1 to either Sequence 1 or Sequence 2. * Sequence 1: Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder). * Sequence 2: Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Participants will receive AZD8630 via test inhaler.
Participants will receive AZD8630 via Monodose inhaler.
Participants will receive AZD8630 via test inhaler.
Research Site
Baltimore, Maryland, United States
Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose
To evaluate the relative bioavailability of AZD8630 test device compared to AZD8630 Monodose device.
Time frame: From Baseline Day 1 to Day 11
Maximum observed plama (peak) drug concentration (Cmax)
To evaluate the Cmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to infinity (AUCinf)
To evaluate the AUCinf of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast)
To evaluate the AUClast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
To evaluate the tmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
The last time point at which the concentration is measured (tlast)
To evaluate the tlast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
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Participants will receive AZD8630 via Monodose inhaler.
Typical elimination rate constant (λz)
To evaluate the λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)
To evaluate the t½λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to 24 (AUC [0-24])
To evaluate the AUC (0-24) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Area under the plasma concentrationcurve from zero to 24, divided by dose (AUC [0-24]/D)
To evaluate the (AUC \[0-24\]/D) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Area under the plasma concentration curve from zero to infinity, divided by dose (AUCinf/D)
To evaluate the AUCinf/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Extrapolated area under the curve from tlast to infinity, expressed as percentage of AUCinf (%AUCextr)
To evaluate the %AUCextr of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Maximum observed plama (peak) drugconcentration, by dose (Cmax/D)
To evaluate the Cmax/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Apparent total body clearence of drugfrom plasma after extravascularadministration (CL/F)
To evaluate the CL/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Volume of distribution (apparent) at steady state following extravascularadministration based on terminalphase (Vz/F)
To evaluate the Vz/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Baseline Day 1 to Day 11
Number of participants with adverse event (AEs)
To further assess the safety and tolerability following single inhaled administration of AZD8630 test formulation and AZD8630 Monodose formulation in healthy participants.
Time frame: From Screening (Day -28) to Follow-up visit (7 days post last dose of AZD8630)
Number of AEs and SAEs associated with test device
To assess the safety and performance of the test device.
Time frame: From Baseline Day 1 to Day 11