Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

Study identifier:D2080C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel group Study to Assess the Safety, Tolerability and Pharmacokinetics after Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD2516, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 80 Years

Date

Study Start Date: 01 Sept 2009

Primary Completion Date: 01 Dec 2009

Study Completion Date: 01 Dec 2009

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Fukuoka, Japan

Arms	Assigned Interventions
Experimental: 1 Capsule administered once orally	Drug: AZD2516 Capsule administered once orally. Specific dose depends on dose panel.
Placebo Comparator: 2 Capsule administered once orally	Drug: Placebo Capsule administered once orally

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1239&filename=CSR-D2080C00004.pdf
Download
CSR-D2080C00004.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Japan Clinical Study Information

+81-6-6453-8011

Investigators

Principal Investigator

Anders Neijber

AstraZeneca R&D Södertälje