Retapamulin Microdialysis Feasibility Study

A Study to Evaluate the Feasibility of Microdialysis to Determine Skin Concentrations of Retapamulin in Healthy Volunteers

NCT01812382•GlaxoSmithKline

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Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.
•The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Subject is willing to provide informed consent.
•Does not use medications containing Retapamulin while participating in the study.
•Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
•Body Mass Index within the range 18.5 to 32 kilogram/ meter\^2 (inclusive).
•The following normal ranges for blood pressure and heart rate are given as a guide: Systolic blood pressure 90 to 140 milimeter of Mercury (mmHg), Diastolic blood pressure 60 to 90 mmHg, and Heart rate 45 to 100 beats per minute (bpm). The investigator may interpret screening vital sign data based on the subject's age, physical state and level of fitness. Subjects with vital sign readings marginally outside the normal range may be included in the study if in the investigator's opinion these values are not clinically significant and will not present a safety risk or affect study assessments.
•A female subject is eligible to participate if she is of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone \> 40 milli international unit/mililiter (mL) and estradiol \< 40 picogram/ml \[\<147 picomoles/Liter\] is confirmatory\]. Females on hormone replacement therapy and whose menopausal status is in doubt will be required to use one of the contraception methods) or Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until study completion (i.e. follow-up phone call). Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until study completion (i.e. follow-up phone call).
•Alanine aminotransferase, alkaline phosphatase and bilirubin \<= 1.5x Upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent).
•QT interval corrected for Heart rate (QTc), QTcB (Bazett's formula) or QTcF (Fridericia's formula) \< 450 millisecond (msec); or QTc \< 480 msec in subjects with Bundle Branch Block.
•Does not currently smoke cigarettes or tobacco and has not smoked within the past 12 months prior to the study.
+1 more criteria

Exclusion Criteria

•Unwillingness or inability to follow the procedures outlined in the protocol
•Subject is mentally or legally incapacitated.
•History of current significant medical illness including cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator deems clinically significant for exclusion of the subject from the study.
•History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
•History of skin conditions including atopic dermatitis, dry skin, or ichtyosis vulgaris.
•Surgical history within 3 months prior to the start of the study.
•Clinically significant acute illness 7 days prior to study start.
•Excessive hair, tattooing, scar tissue, or other tissue damage at the application site that could affect drug recovery or patient safety.
•Use of topical moisturizers (does not include facial moisturizers) 48 hours before the start of and during the study.
•Strenuous exercise 48 hours before the start of and during the study.
+9 more criteria

Locations (1)

GSK Investigational Site

Gainesville, Florida, United States

Key Dates

Start Date

April 2, 2014

Primary Completion Date

May 27, 2014

Completion Date

May 27, 2014

Last Updated

May 15, 2017

Enrollment

ACTUAL participants

Conditions

Skin Infections, Bacterial

Interventions

Retapamulin Microdialysis

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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