A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 after oral Single and Repeated Doses

Study identifier:D1950C00013

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1446, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 80 Years

Date

Study Start Date: 01 Sept 2010

Primary Completion Date: 01 Dec 2010

Study Completion Date: 01 Dec 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Fukuoka, Fukuoka, Japan

Arms	Assigned Interventions
Experimental: 1 Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.	Drug: AZD1446 oral capsule, Moderate Release
Placebo Comparator: 2 Oral capsule. Dose single and followed by 5-day repeated dosing.	Drug: Placebo oral capsule Other Name: Placebo

Documents available

D1950C00013 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Björn Paulsson

AstraZeneca R&D Södertälje