muscle strain
Conditions
Interventions
FIRTECH patch
Sponsors
Sanofi Aventis Groupe
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure 2. Healthy male or female subjects, 18 to 55 years of age, inclusive. 3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. 4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before patch side location randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 3. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening. 4. Use of any medications (prescription or over the counter [OTC]), within 14 days of study product administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day). Other exceptions will only be made if the rationale is clearly documented by the investigator. 5. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study product administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator. 6. Participation in an investigational drug or device study (last dosing of previous study was within 30 days prior to first dosing of this study). 7. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent 8. Positive test for drugs of abuse at screening. 9. Alcohol will not be allowed from at least 24 hours before screening. 10. Active smoker (i.e. on average >3 cigarettes per day in the last 3 months) 11. Excess of caffeine consumption (more than eight cups of coffee or equivalent per day) 12. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). 13. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study. 14. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study. 15. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. 16. Any tattoos, body modifications or other impediments to imaging present in areas to be assessed, i.e. right and left arm and back.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood flow as measured with basal flow through laser speckle contrast imaging (LSCI) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Near-infrared spectrometry (NIRS). Change from baseline of the following parameters will be analyzed: o Blood flow measured as slope of hemoglobin increase in the arm during venous occlusion o Oxygen consumption measured as desaturation slope during arterial occlusion o Reactive hyperemia measured as saturation slope after arterial occlusion o Duration of reactive hyperemia measured as time to return to baseline after arterial occlusion * Laser speckle contrast imaging (LSCI) with post occlusive reactive hyperemia (PORH) and local thermal hyperemia (LTH) challenges. Change from baseline of the following parameters will be analyzed: o Peak flow after arterial occlusion o Peak flow during thermal hyperemia o Plateau flow during thermal hyperemia * Side-stream darkfield microscopy after tape stripping (SDFM). Change from baseline of the following parameters will be analyzed: o Number of vessels, vessel density, perfused number of vessels, perfused vessel density * Multispectral imaging (MSI). Change from baseline of the following parameters will be analyzed: o Skin color, skin texture, skin redness level, skin melanin level * Thermography. Change from baseline of the following parameters will be analyzed: o Skin temperature * AE/SAEs will be recorded from the time of informed consent until the end of the study. The following parameters will be analyzed: o Pre- and post-treatment AEs o TEAEs * Description of any local sensation | — |
Countries
Netherlands
Outcome results
None listed