An Open Label, single centre Mass Balance C14 study in patients with Acute Myeloid Leukaemia (AML)

Study identifier:D1531C00012

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I Open, Non-randomised, Single-centre Study to Assess the Metabolism, Excretion and Pharmacokinetics of AZD1152 and AZD1152 hQPA Following Intravenous Administration of [14C]-AZD1152 in Patients With Acute Myeloid Leukaemia (AML)

Medical condition

Acute Myeloid Leukaemia

Phase

Phase 1

Healthy volunteers

Study drug

AZD1152, C14 AZD1152

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Nov 2009

Primary Completion Date: 01 Jun 2010

Study Completion Date: 01 Jun 2010

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Manchester, United Kingdom

Arms	Assigned Interventions
Experimental: AZD1152 100 mg Lyophile 5 mL Diluent	Drug: AZD1152 100mg Lyophile, 5mL Diluent IV infusion
Experimental: C14 AZD1152 AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.	Drug: C14 AZD1152 radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1167&filename=CSR-D1531C00012.pdf
Download
CSR-D1531C00012.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles Limited, Station House Market Street,

+39 02 957 94346

Investigators

Principal Investigator

Mike Dennis

The Christie Hospital, UK