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A Study to Assess the Effect of Particle Size of AZD7594 on Pharmacokinetics (PK) After a Single Inhaled Dose When Administered Using the Dry Powder Inhaler in Healthy Volunteers

NCT02928354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-02-06

No results posted yet for this study

Summary

This study is an open label, randomized, three-way crossover study to assess the effect of particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects (males aged 18 to 55 years \[inclusive\]). The study will be performed at a single study center.

Conditions

  • Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Treatment A - AZD7594

Particle size Large as a single inhaled dose of 440 µg (nominal dose), administered via DPI

DRUG

Treatment B - AZD7594

Particle size Medium as a single inhaled dose of 440 µg (nominal dose), administered via DPI

DRUG

Treatment C - AZD7594

Particle size Small as a single inhaled dose of 440 µg (nominal dose), administered via DPI

Sponsors & Collaborators

Principal Investigators

  • Dr. Thomas Körnicke · PAREXEL Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-25
Primary Completion
2017-03-21
Completion
2017-03-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928354 on ClinicalTrials.gov