A Single and Multiple Ascending Dose study with AZD9164 given for 13 days in Healthy Male and Female Japanese subjects - JSMAD
Study identifier:D1882C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2009-015560-34
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 after Administration of Single and Multiple Ascending Doses for 13 days in Healthy Male and Female Japanese Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD9164, Placebo
Sex
All
Actual Enrollment
27
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Mar 2010
Primary Completion Date: 01 Jun 2010
Study Completion Date: 01 Jun 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD9164 | Drug: AZD9164 Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD). The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose. |
| Placebo Comparator: 2 | Drug: Placebo Dry powder for inhalation via Turbuhaler, JSMAD. |
Contacts
Investigators
Principal Investigator
Ulrike Lorch
Richmond Pharmacology Ltd.
