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
  Purpose

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.


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, Outcomes Assessor)
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 Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: April 2009
Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: 1
Part A single and multiple dose and part B fractionated dose
Drug: AZD1446
Solution, oral single and multiple dose
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00902993

Locations
Sweden
Research Site
Goteborg, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00902993     History of Changes
Other Study ID Numbers: D1950C00002, EudraCT No. 2008-008389-10
Study First Received: May 12, 2009
Last Updated: September 30, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
MAD
NNR
to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects
AZD1446

ClinicalTrials.gov processed this record on September 18, 2014