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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD9742 IV Infusion | Experimental | Active |
|
| Placebo to AZD9742 IV Infusion | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9742 | Drug | Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals | Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine | Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Ralph A Schutz | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| Placebo to match AZD9742 | Drug | Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) |
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