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Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected for a minimum of 14 days following study drug administration. Safety and tolerability will be monitored throughout the study. A follow-up visit will occur 7-14 days after study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cohort | Experimental | 14C GSK2251052 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C GSK2251052 | Drug | 1500 mg iv dose GSK2251052 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pharmacokinetic parameters for GSK2251052 and radiolabeled compound following intravenous dose | Up to 14 days | |
| Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time | Up to 14 days | |
| Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments | Up to 14 days | |
| Maximum observed concentration | Up to 14 days | |
| Time of occurrence of maximum observed concentration | Up to 14 days | |
| Terminal phase half-life | Up tp 14 days | |
| Systemic clearance of parent drug | Up to 14 days | |
| Volume of distribution | Up to 14 days | |
| Percent recovery of total radiocarbon in urine and feces | Up to 14 days | |
| Urine, fecal recovery and total recovery of radioactivity (as a percentage of total radioactive dose in each interval and cumulative) | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, electrocardiogram and clinical laboratory assessments. | Up to 14 days | |
| Collection of samples for characterization and quantification, or estimation, of GSK2251052-related metabolites in plasma, urine and fecal homogenates to be conducted under a separate protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Zuidlaren | 9471 GP | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23439661 | Background | Bowers GD, Tenero D, Patel P, Huynh P, Sigafoos J, O'Mara K, Young GC, Dumont E, Cunningham E, Kurtinecz M, Stump P, Conde JJ, Chism JP, Reese MJ, Yueh YL, Tomayko JF. Disposition and metabolism of GSK2251052 in humans: a novel boron-containing antibiotic. Drug Metab Dispos. 2013 May;41(5):1070-81. doi: 10.1124/dmd.112.050153. Epub 2013 Feb 25. |
| Label | URL |
|---|---|
| Results for study 115243 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Up to 14 days |