Last updated: 11/07/2018 04:53:33
Cantharidin-induced skin blister for testing anti-inflammatory effects of macrolides
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Utility of the cantharidin-induced skin blister assay for evaluation of anti-inflammatory effects of macrolides in healthy volunteers
Trial description: The purpose of this study is to investigate the utility of the cantharidin-induced skin blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male volunteers.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Tolerability and safety of cantharidin-induced skin blister assay (as determined by AEs, pain intensity, systemic inflammatory response, healing time, and cosmetic appearance of blister area)
Timeframe: Study duration
Total cell count, neutrophil count and monocyte/macrophage count in blister fluid.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Secondary outcomes:
Monocyte/macrophage phenotype in blister fluid.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Inflammatory mediators in blister fluid.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Markers of neutrophil activation.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Inflammatory mediators in serum.
Timeframe: Part C: end of treatment and potentially 3 weeks later
PK parameters for azithromycin in plasma and whole blood following the last dose of azithromycin, as well as azithromycin concentration in PMNs and, if possible, in peripheral blood mononuclear cells at selected time points.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Exploratory Outcome: Additional inflammatory mediators of interest may be determined.
Timeframe: Part C: end of treatment and potentially 3 weeks later
Interventions:
Other: Cantharidin
Drug: Azithromycin
Drug: Placebo
Enrollment:
44
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
T Pene Dumitrescu, T Anic-Milic, K Oreskovic, J Padovan, KLR Brouwer, P Zuo, VD Schmith . Development of a Population Pharmacokinetic Model to Describe Azithromycin Whole Blood and Plasma Concentrations Over Time in Healthy Subjects. Antimicrob Agents Chemother. 2013;57(7):3194-3201.
Medical condition
Inflammation
Product
GR61229, azithromycin
Collaborators
GSK
Study date(s)
June 2009 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy as determined by a responsible and experienced physician.
- Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Subjects with very fair skin type.
- Presence on either forearm of tattoos, naevi, scars, keloids, hyperpigmentation, excessive hair or any skin abnormalities that may, in the opinion of the investigator, interfere with study assessments.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy as determined by a responsible and experienced physician.
- Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- The subject has a body weight of more than or equal to 50 kg and a BMI 18.5 to 30 kg/m2.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria:
- Subjects with very fair skin type.
- Presence on either forearm of tattoos, naevi, scars, keloids, hyperpigmentation, excessive hair or any skin abnormalities that may, in the opinion of the investigator, interfere with study assessments.
- Subjects with a history of keloids, skin allergy, hypersensitivity or contact dermatitis, including previous reactions to dressings to be used in the study.
- Subjects with a history of lymphangitis and/or lymphoedema.
- Subjects with a history of HIV infection, hepatitis B or C.
- A positive pre-study drug/alcohol screen.
- Use of prescription or non-prescription drugs, including ergot derivatives e.g. dihydroergotamine (Dihydergot), vitamins, herbal and dietary supplements (including St John’s Wort) within whichever is the longer period of 14 days or 5 half-lives (if known) prior to the first challenge day, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56-day period. For part C only:
- QTcB or QTcF >450 msec, based on average QTc value of triplicate ECGs obtained over a brief recording period, if the first measurement shows abnormal QTc value.
- History of sensitivity to azithromycin, macrolide/ketolide antibiotics 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.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-27-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 112593 can be found on the GSK Clinical Study Register.
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