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A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects

NCT02648438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-15

Study results available
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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)

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

AZD7594 Solution for infusion (150 μg intravenous formulation)

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

DRUG

AZD7594 Oral suspension (1200 μg oral formulation)

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

DRUG

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

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

DRUG

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

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

DRUG

AZD7594 Pressurized inhalation suspension (400 μg) by pMDI

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

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, M.D · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2016-06-01
Completion
2016-06-01

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 NCT02648438 on ClinicalTrials.gov