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
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 April 22, 2014