A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title: An Open Label, Partially Randomized, Four-period Study in Healthy Male Subjects to Investigate the Bioavailability and Pharmacokinetics of a Single Dose of AZD7594 When Administered Intravenously, Orally and Inhaled Via Two Different Dry Powder Inhalers (DPI) and a Pressurized Metered-dose Inhaler (pMDI)

Status Completed

Clinical Trial Summary

This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)

Clinical Trial Description

This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy male subjects, performed at a single study center. All subjects will receive the 4 of the 5 treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal cohorts, multiple-dose DPI and pMDI. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma,
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT02648438
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Completion date: June 2016