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Withdrawn due to the local Radiation Safety Committee refusing to approve it.
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The purpose of this study is to assess distribution, metabolism, and excretion of radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | [14C]-AZD9742 1000 mg intravenous over 2 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-AZD9742 | Drug | 1000 mg intravenous over 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion. | 12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first. | Range of 12 hours pre dose to 168 hours post dose |
| To evaluate the excretion of 14C (mass balance) in urine and feces after a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion. | 12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first. | Range of 12 hours pre dose to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AZD9742 after a single intravenous 14C administration of AZD9742, by assessing a panel of measures: Adverse Events, vital sign evaluations, physical examination, electrocardiograms (ECG) and clinical laboratory parameters. | ||
| To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MD | AstraZeneca | Study Director |
| Ralph Schutz, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Immediately prior to the end of the infusion, 4 hours after the end of the infusion and 24 hours after the start of the infusion. |