A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses
This study has been completed.
Information provided by:
First received: September 9, 2010
Last updated: February 16, 2011
Last verified: February 2011
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 in Young and Elderly Healthy Japanese Volunteers After Oral Single and Repeated Doses|
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG. [ Time Frame: During the whole study period, ca. 50 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers. [ Time Frame: PK samplings are taken at defined timepoints during residential period, 10 days. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.
oral capsule, Moderate Release
Placebo Comparator: 2
Oral capsule. Dose single and followed by 5-day repeated dosing.
Other Name: Placebo
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199315
Sponsors and Collaborators
|Study Director:||Björn Paulsson||AstraZeneca R&D Södertälje|
|Principal Investigator:||Shunji Matsuki, PhD||Kyushu Clinical Pharmacology Research Clinic|