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

NCT02645253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-02-19

Study results available
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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)

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease COPD

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Esther Yoon, M.D · California Clinical Trials Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2016-04-17
Completion
2016-04-17

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02645253 on ClinicalTrials.gov