NCT02645253

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men

A Phase I, Randomized, Single-blind, Placebo-controlled, Sequential-group, Single-center Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of AZD7594 Given Once Daily as Inhaled Formulation in Healthy Japanese Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)

Detailed description

This is a phase I, randomized, single-blind, placebo controlled, sequential-group design study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 after single and multiple ascending doses given once daily by inhalation in healthy male Japanese subjects, compared with placebo

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease COPD

Interventions

Type	Name	Description
DRUG	AZD7594 inhalation powder (200 μg)	200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI)
DRUG	AZD7594 inhalation powder (400 μg)	Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI
DRUG	AZD7594 pressurized inhalation suspension (200 μg)	400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
DRUG	AZD7594 placebo inhalation powder	AZD7594 placebo inhalation powder via multi-dose DPI
DRUG	AZD7594 placebo pressurized inhalation suspension	AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

Timeline

• Start date: 2016-01-12
• Primary completion: 2016-04-17
• Completion: 2016-04-17
• First posted: 2016-01-01
• Last updated: 2018-02-19
• Results posted: 2018-02-19

Locations

1 site across 1 country: United States