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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD5847 oral suspension | Experimental | Active |
|
| Placebo to AZD5847 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5847 | Drug | Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1. Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals | Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses. | Samples taken during the residential period at defined timepoints pre-dose and post-dose. | |
| To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Patricia A Meier, MSc | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| C453362 | posizolid |
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| Placebo to AZD5847 | Drug | In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1 |
|
| Samples taken during the residential period at defined timepoints pre-dose and post-dose |