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
No
Study drug
AZD1152, C14 AZD1152
Sex
All
Actual Enrollment
5
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Mike Dennis
The Christie Hospital, UK
