AZD5423 Multiple Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01037504
First received: December 20, 2009
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects


Condition Intervention Phase
Healthy
Drug: AZD5423
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables: adverse events [ Time Frame: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics profile: concentration of AZD5423 in plasma [ Time Frame: Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints. ] [ Designated as safety issue: No ]
  • Investigation of PD effects [ Time Frame: Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: AZD5423
Drug: AZD5423
Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
Placebo Comparator: B
Drug: Placebo
Drug: Placebo
Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 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
  • 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: NCT01037504

Locations
United Kingdom
Research Site
London Bridge, Greater London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham Quintiles Drug Research Unit at Guy's Hospital, London, UK
Study Director: Jorup Carin AstraZeneca R&D, Lund, Sweden
  More Information

No publications provided

Responsible Party: Carin Jorup, MD, Medical Science Director, Emerging respiratory, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT01037504     History of Changes
Other Study ID Numbers: D2340C00002, EudraCT No: 2009-016611-38
Study First Received: December 20, 2009
Last Updated: May 19, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
safety
tolerability
healthy
inhalation
Healthy volunteers

ClinicalTrials.gov processed this record on August 28, 2014