Study of uptake, break down and elimination of an investigational drug in healthy volunteers - MB

Study identifier:D3690C00017

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers with Different CYP2D6 Genotype

Medical condition

Alzheimer's disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3480

Sex

Male

Actual Enrollment

Study type

Interventional

Age

35 Years - 65 Years

Date

Study Start Date: 01 Oct 2008

Primary Completion Date: 01 Oct 2009

Study Completion Date: 01 Oct 2009

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research site

MACCLESFIELD, Cheshire, United Kingdom

Arms	Assigned Interventions
Experimental: AZD3480 iv Single iv infusion AZD3480	Drug: AZD3480 Iv single dose, 4-hour infusion of 25 mg
Experimental: Oral [14C] AZD3480 Single oral dose [14C]AZD3480	Drug: AZD3480 Oral solution single dose of 50 mg

Documents available

D3690C00017 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles London

+ 44 0800 634 1132

Investigators

Principal Investigator

Björn Paulsson

AstraZeneca Södertälje, Sweden