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
Overview
- Phase
- Phase 1
- Intervention
- AZD1446
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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,
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
Part A single and multiple dose and part B fractionated dose
Intervention: AZD1446
2
Intervention: Placebo
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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)