CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
AZD7594 inhalation powder (200 μg) +4 moredrug
Likely dose
AZD7594 inhalation powder (200 μg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02645253
NCT02645253Phase 1Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jan 1, 2016·Updated Feb 19, 2018

In Brief

A Phase 1 clinical trial evaluating AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg), and 3 other interventions for Asthma and Chronic Obstructive Pulmonary Disease COPD. Completed, enrolled 27 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Chronic Obstructive Pulmonary Disease COPD
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 1, 2016
Enrollment StartJan 12, 2016
Primary CompletionApr 17, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.5 years ago

Interventions

AZD7594 inhalation powder (200 μg)drug

200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI)

AZD7594 inhalation powder (400 μg)drug

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

AZD7594 pressurized inhalation suspension (200 μg)drug

400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

AZD7594 placebo inhalation powderdrug

AZD7594 placebo inhalation powder via multi-dose DPI

AZD7594 placebo pressurized inhalation suspensiondrug

AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)