A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00997308
First received: October 12, 2009
Last updated: January 21, 2010
Last verified: January 2010

October 12, 2009
January 21, 2010
October 2009
December 2009   (final data collection date for primary outcome measure)
To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure). [ Time Frame: During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00997308 on ClinicalTrials.gov Archive Site
To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff. [ Time Frame: PK sampling taken at defined timepoints during the treatment period (study days 1-28) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment

This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD1446
    Solution, oral, for 4 weeks
  • Drug: Placebo
  • Experimental: AZD1446 Low
    Low dose of AZD1446
    Intervention: Drug: AZD1446
  • Experimental: AZD1446 High
    High dose of AZD1446
    Intervention: Drug: AZD1446
  • Placebo Comparator: Placebo
    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
97
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85
  • Body mass index (BMI) between 18 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 including severe food allergy as judged by the investigator.
Both
65 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00997308
D1950C00009, EudraCT No.2009-013390-18
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Bo Fransson, MD, PhD AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden
Study Director: Björn Paulsson, MD, PhD AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden
AstraZeneca
January 2010

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