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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1446; Drug: Placebo

• Registration Number: NCT00902993
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-30
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1446	Part A single and multiple dose and part B fractionated dose
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden