drugset / Trial / NCT02967159

A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants

NCT02967159

Phase 1 Completed 14 enrolled AstraZeneca Parexel · collab
RandomizedCrossoverOpen-labelTreatment

Summary

AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist with the potential for once daily treatment of asthma and COPD in fixed dose combination (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This study will be conducted in healthy male subjects to minimize the effects of concomitant disease states or medications on study measurements.

Timeline

Start
2016-11-24
Primary completion
2017-04-06
Completion
2017-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Abediterol Small molecule 2.5 ug Inhaled
Subject VELSECORAT Other / unclassified 440 ug Inhaled