A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.
NCT Number: NCT06531811
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: AZD8630 (test formulation) via test inhaler|DRUG: AZD8630 (reference formulation) via Monodose inhaler|DEVICE: Test inhaler|DEVICE: Monodose inhaler
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-06
Completion Date: 2024-10-08
Locations: Research Site, Baltimore, Maryland, 21225, United States

Summary:
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.

Primary Outcome Measures: 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., From Baseline Day 1 to Day 11
Secondary Outcome Measures: 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., 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., 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., 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., 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., From Baseline Day 1 to Day 11|Typical elimination rate constant (λz), To evaluate the λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., From Baseline Day 1 to Day 11