Trial record 2 of 11 for:    AZD1446

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
  Purpose

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 Intervention Phase
Healthy
Drug: AZD1446
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, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 97
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT00997308

Locations
Sweden
Research
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00997308     History of Changes
Other Study ID Numbers: D1950C00009, EudraCT No.2009-013390-18
Study First Received: October 12, 2009
Last Updated: January 21, 2010
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
AZD1446
to investigate safety and tolerability in Healthy subjects during 4 weeks of administration

ClinicalTrials.gov processed this record on October 23, 2014