Study to investigate the activity of AZD5122 when given as a single dose to healthy male subjects

Study identifier:D2650C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5122, Placebo

Sex

Male

Actual Enrollment

100

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Sept 2009

Primary Completion Date: -

Study Completion Date: 01 Nov 2009

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics 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

NOTTINGHAMSHIRE, United Kingdom

Arms	Assigned Interventions
Experimental: 1 AZD5122 oral suspension (part A and B)	Drug: AZD5122 A single dose of oral suspension
Placebo Comparator: 2 Placebo oral suspension (part A)	Drug: Placebo A single dose of oral suspension
Experimental: 3 AZD5122 oral and IV infusion (part B)	Drug: AZD5122 A single dose of oral suspension Drug: AZD5122 A single intravenous infusion

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1285&filename=CSR-D2650C00006.pdf
Download
CSR-D2650C00006.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Volunteer recruitment officer

+44 (0) 1509 645950

nottingham.volunteers@astrazeneca.com

Investigators

Principal Investigator

Andrew Sparrow

AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH