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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.
This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin Administration | Experimental | Single dose of telavancin administered as a 1-hour intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | A single dose of telavancin as a 1-hour intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of adverse events of any severity regardless of relationship to study drug | 48 hours | |
| Area-under-the-plasma concentration-time curve (AUC0-infinity) | To estimate the telavancin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC0-infinity) after a single dose of telavancin in healthy adult participants | 48 hours |
| Maximum plasma concentration (Cmax) | To estimate the telavancin pharmacokinetic parameter maximum plasma concentration (Cmax) after a single dose for intravenously dosed telavancin to healthy adult participants | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith A. Rodvold, Pharm.D. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29311094 | Derived | Bunnell KL, Pai MP, Sikka M, Bleasdale SC, Wenzler E, Danziger LH, Rodvold KA. Pharmacokinetics of Telavancin at Fixed Doses in Normal-Body-Weight and Obese (Classes I, II, and III) Adult Subjects. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02475-17. doi: 10.1128/AAC.02475-17. Print 2018 Apr. |
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| ID | Term |
|---|---|
| C487637 | telavancin |
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