Study identifier:D8900C00005
ClinicalTrials.gov identifier:NCT04480879
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomised, 3 Period, Single dose, Open-label Crossover Study to Evaluate the Systemic Exposure of AZD8154 While Administered via Inhalation Using a Nebuliser Formulation and a Monodose Dry Powder Inhaler (DPI) Formulation in Healthy Subjects
asthma
Phase 1
Yes
AZD8154 nebuliser, AZD8154 Monodose DPI presented in capsules, AZD8154 Placebo Monodose DPI presented in capsules
All
10
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Aug 2021 by AstraZeneca
AstraZeneca
PAREXEL
This study is intended to evaluate the systemic pharmacokinetic (PK) characteristics and the safety of AZD8154 following administration of the Monodose DPI formulation compared with the administration of the nebuliser suspension.
This study will be a randomised, open-label, 3-period, single-dose, single-centre, crossover study in healthy males and healthy females of non-childbearing potential. The study will comprise: • A Screening Period of maximum 28 days; • Three treatment periods during which subjects will be resident at the Clinical Unit from the morning of the day before dosing with AZD8154 or placebo (Day 1) until 72 hours following dosing for collection of PK samples; discharged on the morning of Day 4 of each treatment period; • A Follow up Visit within 6 ± 1 days after last dose administration of investigational medicinal products (IMPs) (i.e., AZD8154 or placebo). A total of 15 healthy subjects will be randomised in this study to ensure that at least 12 subjects are evaluable. Each subject will be involved in the study for approximately 9 weeks.
Location
Location
Berlin, Germany, 14050
Arms | Assigned Interventions |
---|---|
Experimental: AZD8154 nebuliser suspension The study subjects will receive 1 mg delivered dose of AZD8154 nebuliser suspension | Drug: AZD8154 nebuliser Nebuliser suspension |
Experimental: AZD8154 Monodose The study subjects will receive 1 mg capsule delivered dose of AZD8154 Monodose DPI formulation | Drug: AZD8154 Monodose DPI presented in capsules AZD8154 Monodose DPI formulation delivered dose |
Placebo Comparator: AZD8154 Placebo Monodose DPI The study subjects will receive AZD8154 placebo Monodose DPI formulation dosed to correspond to 1 mg delivered dose AZD8154 Monodose DPI formulation | Drug: AZD8154 Placebo Monodose DPI presented in capsules The dose correspond to AZD8154 Monodose DPI formulation |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.