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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01166698
Other study ID # D3020C00001
Secondary ID
Status Completed
Phase Phase 1
First received July 20, 2010
Last updated November 8, 2011
Start date August 2010
Est. completion date January 2011

Study information

Verified date November 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD9819
Inhaled single doses of suspension via SPIRA nebuliser
AZD9819
Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days
Placebo
Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

Locations

Country Name City State
United Kingdom Research Site London

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab) Frequent safety measurements during the study from screening period to follow-up Yes
Secondary Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma Multiple PK blood samples from pre-dose until 96 hours post last dose No
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