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Retapamulin Microdialysis

Phase 1

Skin Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Last Updated: May 15, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

Retapamulin Microdialysis · 1 trial · 1 indication

Phase 1 1
NCT01812382Retapamulin Microdialysis Feasibility StudySkin Infections, Bacterial
COMPLETED3 Analytics
PHASE1COMPLETED
Retapamulin Microdialysis Feasibility Study
Skin Infections, BacterialUnlock trial analytics

Study Endpoints

Primary Endpoints

Retapamulin concentrations in the dialysate samples
Single day

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

Secondary Endpoints

Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by number of participants with Adverse Events (AEs)
Up to 4 days
Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Laboratory parameters
Single day
Safety and tolerability of the microdialysis technique with perfused Retapamulin assessed by Vital Sign measurements
Single day (Pre-dose and at 7th hour Post-dose)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Microdialysis armEXPERIMENTALThree 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.

Interventions

NameTypeDescription
Retapamulin MicrodialysisDRUGAfter 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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Retapamulin Microdialysis

What is Retapamulin Microdialysis used for?

Retapamulin Microdialysis is being studied for use in bacterial skin infections. It is an investigational small molecule in Phase 1 clinical development. The drug is being evaluated through a microdialysis feasibility study to assess its potential in treating these infections.

Who makes Retapamulin Microdialysis?

Retapamulin Microdialysis is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this investigational small molecule for bacterial skin infections.

What phase is Retapamulin Microdialysis in?

Retapamulin Microdialysis is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, with no active trials currently ongoing.

What clinical trials is Retapamulin Microdialysis in?

Retapamulin Microdialysis has one completed clinical trial, NCT01812382, titled 'Retapamulin Microdialysis Feasibility Study.' This Phase 1 study enrolled 3 participants in the United States and included healthy volunteers aged 18 years and older.

Is Retapamulin Microdialysis the same as retapamulin?

Retapamulin Microdialysis is a formulation or delivery method of retapamulin, an antibiotic. The microdialysis approach is being studied to measure drug levels in tissues. The clinical trial NCT01812382 evaluates this specific microdialysis technique for bacterial skin infections.