NCT02648438

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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)

Detailed 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.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	AZD7594 Solution for infusion (150 μg intravenous formulation)	Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV
DRUG	AZD7594 Oral suspension (1200 μg oral formulation)	0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral
DRUG	AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)	Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler)
DRUG	AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)	Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI)
DRUG	AZD7594 Pressurized inhalation suspension (400 μg) by pMDI	Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg

Timeline

• Start date: 2016-01-12
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-01-07
• Last updated: 2017-06-15
• Results posted: 2017-06-15

Locations

1 site across 1 country: United States