Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902993
• Other study ID #: D1950C00002
• Secondary ID: EudraCT No. 2008
• Status: Completed
• Phase: Phase 1
• First received: May 12, 2009
• Last updated: September 30, 2009
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1446
Solution, oral single and multiple dose
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,		during the whole study period, ca 50 days	Yes
Primary	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.		during the whole study period, ca 43 days	Yes
Secondary	Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.		PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B	No
Secondary	Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.		PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B	No