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The purpose of the study is to assess how AZD1152 is absorbed or excreted in and out of the body in patients with Acute Myeloid Leukaemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1152 | Experimental | 100 mg Lyophile 5 mL Diluent |
|
| C14 AZD1152 | Experimental | AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1152 | Drug | 100mg Lyophile, 5mL Diluent IV infusion |
| |
| C14 AZD1152 |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of total radioactivity, AZD1152 and AZD1152 hQPA in plasma and their ratios, the concentration of total radioactivity in blood and its blood/plasma concentration ratios | Day1-10 | |
| The derived plasma and urinary pharmacokinetic parameters for AZD1152 and AZD1152 hQPA The percentage of the [14C] AZD1152 dose recovered in urine, faeces and vomit (if presented), and the percentage of radioactive dose recovered overall. | Day1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), serious adverse events (SAEs) and deaths, Discontinuations for tolerability reasons, vital signs (temperature, blood pressure [BP], pulse rate and respiratory rate [RR]) | AEs, SAEs, deaths, discontinuations ongoing to completion and vitals over 22 days - Screening, PD Day 1, Days 3, 6, 9, 14, 22 | |
| Electrocardiogram (ECG) parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Dennis, MD | The Christie Hospital, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Manchester | United Kingdom |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C520647 | 2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate |
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| Drug |
radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion |
|
| Screening, PD Day 1, Day 4 |
| Clinical chemistry, haematology (including clotting parameters) and urinalysis; physical examination | Chemistry/Heamatology - Screening, PD Day 1, Days 3, 6, 9, 14, 22Urinalysis - Screening, PD Day 1 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |