NCT01635985

A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability When Administered Inhaled Via a New Dry Powder Inhaler, Turbuhaler, Spira Nebulizer and I-neb AAD System

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects

Detailed description

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system

Conditions

• Bioavailability and AUC

Interventions

Type	Name	Description
DRUG	AZD5423	solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423
DRUG	AZD5423	nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
DRUG	AZD5423	nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
DRUG	AZD5423	nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
DRUG	AZD5423	dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423
DRUG	AZD5423	dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-10
• Last updated: 2015-01-14

Locations

1 site across 1 country: United Kingdom