CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
AZD7594 Solution for infusion (150 μg intravenous formulation) +4 moredrug
Likely dose
AZD7594 Solution for infusion (150 μg intravenous formulation)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/NCT02648438
NCT02648438Phase 1Completed

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)

AstraZeneca·interventional·Posted Jan 7, 2016·Updated Jun 15, 2017

In Brief

A Phase 1 clinical trial evaluating AZD7594 Solution for infusion (150 μg intravenous formulation), AZD7594 Oral suspension (1200 μg oral formulation), and 3 other interventions for Asthma and Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 30 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 7, 2016
Enrollment StartJan 12, 2016
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.5 years ago

Interventions

AZD7594 Solution for infusion (150 μg intravenous formulation)drug

Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV

AZD7594 Oral suspension (1200 μg oral formulation)drug

0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral

AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)drug

Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler)

AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)drug

Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI)

AZD7594 Pressurized inhalation suspension (400 μg) by pMDIdrug

Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg