Research Site
Baltimore, Maryland, 21225, United States
NCT Number: NCT06531811
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
This is a randomized, open-label, 2- treatment, 2- period study with a duration of approximately 6 weeks.
The Study will comprise of:
Participants will be randomized 1:1 to either Sequence 1 or Sequence 2.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive AZD8630 via test inhaler.
Participants will receive AZD8630 via Monodose inhaler.
Participants will receive AZD8630 via test inhaler.
Participants will receive AZD8630 via Monodose inhaler.
Time frame: From Baseline Day 1 to Day 11
To evaluate the relative bioavailability of AZD8630 test device compared to AZD8630 Monodose device.
Time frame: From Baseline Day 1 to Day 11
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
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
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
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
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
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
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
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
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
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
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
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
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
To evaluate the Vz/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.
Time frame: From Screening (Day -28) to Follow-up visit (7 days post last dose of AZD8630)
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 Baseline Day 1 to Day 11
To assess the safety and performance of the test device.
AstraZeneca
Industry
A Randomized, Open-label, Single-dose, 2-Treatment, 2-Period, Crossover Study to Assess the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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