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
  Purpose

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 Intervention Phase
Healthy Volunteers
Safety
Tolerability
Drug: AZD9819
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166698

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01166698     History of Changes
Other Study ID Numbers: D3020C00001
Study First Received: July 20, 2010
Last Updated: November 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
inhalation

ClinicalTrials.gov processed this record on October 02, 2014