Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00902993
First received: May 12, 2009
Last updated: September 30, 2009
Last verified: September 2009

May 12, 2009
September 30, 2009
April 2009
Not Provided
  • Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers, [ Time Frame: during the whole study period, ca 50 days ] [ Designated as safety issue: Yes ]
  • Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers. [ Time Frame: during the whole study period, ca 43 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00902993 on ClinicalTrials.gov Archive Site
  • Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers. [ Time Frame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B ] [ Designated as safety issue: No ]
  • Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers. [ Time Frame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses

This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD1446
    Solution, oral single and multiple dose
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Part A single and multiple dose and part B fractionated dose
    Intervention: Drug: AZD1446
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2009
Not Provided

Inclusion Criteria:

  • Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80
  • Body mass index (BMI) between 19 and 30 kg/m2
  • Clinically normal findings on physical examination

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • History of severe allergy/hypersensitivity reactions
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00902993
D1950C00002, EudraCT No. 2008-008389-10
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Björn Paulsson, MD, PhD AstraZeneca
Principal Investigator: Marianne Hartford, MD PhD AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden
Principal Investigator: Ingemar Bylesjo, MD PhD AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden
AstraZeneca
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP