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

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ClinicalTrials.gov Identifier: NCT00997308
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1446 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD1446 Low
Low dose of AZD1446
 Drug: AZD1446
Solution, oral, for 4 weeks
Experimental: AZD1446 High
High dose of AZD1446
 Drug: AZD1446
Solution, oral, for 4 weeks
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997308


Locations
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Sweden
Research
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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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
More Information
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00997308    
Other Study ID Numbers: D1950C00009
EudraCT No.2009-013390-18
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010
Keywords provided by AstraZeneca:
AZD1446
to investigate safety and tolerability in Healthy subjects during 4 weeks of administration