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

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ClinicalTrials.gov Identifier: NCT01166698
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Safety Tolerability Drug: AZD9819 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : August 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: AZD9819
Inhaled suspension
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)
Placebo Comparator: Placebo
Inhaled suspension
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166698


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01166698     History of Changes
Other Study ID Numbers: D3020C00001
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
inhalation