A single dose study to assess the safety, effects, and blood and urine drug levels of AZD3293 in healthy subjects

Study identifier:D5010C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers

Medical condition

Healthy young volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3293, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Dec 2012

Primary Completion Date: 01 May 2013

Study Completion Date: 01 May 2013

Study design

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

Verification:

Verified 01 Aug 2013 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Baltimore, MD, United States

Arms	Assigned Interventions
Experimental: AZD3293 Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg	Drug: AZD3293 Oral solution
Placebo Comparator: Placebo Placebo given (2 subjects in each cohort)	Drug: Placebo Oral solution

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

www.baltimoretrials.com -

1-877-617-8839

Investigators

Principal Investigator

Robert C Alexander

AstraZeneca