Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01166698

First received: July 20, 2010

Last updated: November 8, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2010
Last Updated Date	November 8, 2011
Start Date ^ICMJE	August 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 20, 2010)	Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent safety measurements during the study from screening period to follow-up ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01166698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 20, 2010)	Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma [ Time Frame: Multiple PK blood samples from pre-dose until 96 hours post last dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Official Title ^ICMJE	A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Brief Summary	The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers Safety Tolerability
Intervention ^ICMJE	Drug: AZD9819 Inhaled single doses of suspension via SPIRA nebuliser Drug: AZD9819 Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days Other Name: Part B (multiple ascending doses) Drug: Placebo Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B) Other Name: Part A and B
Study Arm (s)	Experimental: AZD9819 Inhaled suspension Interventions: Drug: AZD9819 Drug: AZD9819 Placebo Comparator: Placebo Inhaled suspension Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Exclusion Criteria: Any clinically significant disease or disorder Any clinically significant abnormalities at screening examination Use of any prescribed or non-prescribed medication
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01166698
Other Study ID Numbers ^ICMJE	D3020C00001
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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