Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01812382 | Retapamulin Microdialysis Feasibility Study | PHASE1 | COMPLETED | 3 | — | — | Apr 2, 2014 | May 27, 2014 | May 15, 2017 | 1 | United States |
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
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
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 ...