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This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects will be enrolled and complete the study procedures. Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure. After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection will continue every 30 minutes for 4 hours. The approximate duration of study including follow-up is 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microdialysis arm | Experimental | Three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure/infusion using a microdialysis device. All subjects will receive Sodium Chloride solution perfused for 30 minutes followed by Retapamulin perfusion for 90 minutes and then Saline perfusion will occur during the washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retapamulin Microdialysis | Drug | After a 30 minutes equilibration period of the microdialysis procedure/infusion with normal saline solution, 50nanogram (ng)/mL Retapamulin injectable solution will be infused at a flow rate of 1.5 microliter/minute over a period of 90 minutes. The total dose perfused for each of the 3 microdialysis tubes will be 6.75ng. |
| Measure | Description | Time Frame |
|---|---|---|
| Retapamulin concentrations in the dialysate samples | Retapamulin concentrations in the dialysate samples will be collected to calculate the length of time needed until disappearance of the drug in the dialysate (washout) and the percentage of drug recovered following perfusion of Retapamulin solution by microdialysis to the thigh of healthy volunteers. Microdialysis is a minimally-invasive sampling technique that is used for continuous measurement of free, unbound analyte concentrations in the extracellular fluid of virtually any tissue | Single day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by number of participants with Adverse Events (AEs) | Adverse event collection and recording will begin with first dose and continue until the final follow-up visit | Up to 4 days |
| Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Laboratory parameters |
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Inclusion Criteria:
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with clinically significant lab values outside the normal range should always be excluded from enrollment.
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 | Gainesville | Florida | 32610 | United States |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study 117151 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117151 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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|
Laboratory parameters include: Hematology, Clinical Chemistry and additional parameters |
| Single day |
| Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Vital Sign measurements | Vital Signs include: Systolic and Diastolic Blood Pressure and Pulse Rate. Pre-dose Vital Signs will be performed in triplicate and all other will be done in duplicate | Single day (Pre-dose and at 7th hour Post-dose) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117151 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |