Evaluation of AZD8154 Concentrations in Blood

Asthma Clinical Trial

Official title: 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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT04480879
• Study type: Interventional
• Source: AstraZeneca
• Status: Terminated
• Phase: Phase 1
• Start date: July 17, 2020
• Completion date: September 2, 2020