Clinical trial NCT00902993: Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: MAD
NNR
to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects
AZD1446
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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,
timeFrame: during the whole study period, ca 50 days
measure: 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.
timeFrame: during the whole study period, ca 43 days
Secondary outcomes:
measure: Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.
timeFrame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B
measure: Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.
timeFrame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Björn Paulsson, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden
name: Marianne Hartford, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden
name: Ingemar Bylesjo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: