NCT01290198

Brief Summary

The objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods for the study of functional microcirculation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

February 3, 2011

Last Update Submit

September 4, 2012

Conditions

Healthy Volunteers

Keywords

epoxy-eicosatrienoic acidLaser DopplerEndothelium derived hyperpolarizing factorcutaneous microcirculationpost-occlusive hyperaemiathermal hyperemiaintradermal microdialysisfluconazole

Outcome Measures

Primary Outcomes (1)

  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰)

    maximum amplitude as a percentage of maximal vasodilation and area under the curve: AUC

    2 hours

Secondary Outcomes (3)

  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰)

    2 hours

  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without ANESDERM ® (lidocaine, prilocaine)

    2 hours

  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without N(G)-nitro-L-arginine-methyl ester (L-NMMA)

    2 hours

Study Arms (4)

Vehicle without ANESDERM (lidocaine, prilocaine)

PLACEBO COMPARATOR
Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Vehicle with ANESDERM (lidocaine, prilocaine)

ACTIVE COMPARATOR
Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Fluconazole without ANESDERM (lidocaine, prilocaine)

ACTIVE COMPARATOR
Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Fluconazole with ANESDERM (lidocaine, prilocaine)

ACTIVE COMPARATOR
Drug: Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)

Interventions

Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)DRUG

At the first three visits, volunteers will receive fluconazole (650µmol/L and 6.5mmol/L) and vehicle (NaCl 0.9%), and at the fourth, these plus L-NMMA (10mmol/L), delivered by microdialysis in the forearm, with or without anesthesia. Then post-occlusive hyperemia and thermal hyperemia are performed.

Fluconazole with ANESDERM (lidocaine, prilocaine)Fluconazole without ANESDERM (lidocaine, prilocaine)Vehicle with ANESDERM (lidocaine, prilocaine)Vehicle without ANESDERM (lidocaine, prilocaine)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 35 years
  • Affiliated to the French social security system or beneficiary a similar regime
  • In good health

You may not qualify if:

  • Active smoker
  • Pregnant, parturient, breast-feeding
  • Person deprived of civil liberties by judicial or administrative measure; person under legal protection,
  • Minor less than 18 years
  • Person has exceeded the annual compensation for participation in trials
  • Person with active disease or with prolonged treatment, excluding oral contraceptives and paracetamol
  • Asthma, urticaria, angioedema, known drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Unit

Grenoble, 38000, France

Location

MeSH Terms

Interventions

NG-Nitroarginine Methyl Esteromega-N-Methylarginine

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Jean-Luc Cracowski, MD,PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 4, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

FR(1)