Retapamulin Microdialysis Feasibility Study
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Evaluate the Feasibility of Microdialysis to Determine Skin Concentrations of Retapamulin in Healthy Volunteers|
- Retapamulin concentrations in the dialysate samples [ Time Frame: Single day ] [ Designated as safety issue: No ]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
- Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by number of participants with Adverse Events (AEs) [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]Adverse event collection and recording will begin with first dose and continue until the final follow-up visit
- Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Laboratory parameters [ Time Frame: Single day ] [ Designated as safety issue: No ]Laboratory parameters include: Hematology, Clinical Chemistry and additional parameters
- Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Vital Sign measurements [ Time Frame: Single day (Pre-dose and at 7th hour Post-dose) ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Microdialysis arm
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.
Drug: Retapamulin Microdialysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812382
|United States, Florida|
|GSK Investigational Site|
|Gainesville, Florida, United States, 32610|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|