Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P

This is an interventional prevention trial for Pruritus focused on measuring itch Read More

Inclusion Criteria:

• Males 18 - 45 years of age, inclusive;
• Non-smokers, per medical history, or ex-smokers for a period of ≥1 year;
• Subjects with Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2 (BMI = weight (kg)/ [height (m)]2);
• Vital signs (in sitting position after 3 minutes of rest) which are within the ranges shown below (inclusive):
• Body temperature between 35.4-37.8 °C;
• Systolic blood pressure between 91-130 mmHg;
• Diastolic blood pressure between 51-90 mmHg;
• Pulse rate between 50-100 bpm;
• Respiratory rate between 10-20 breaths per minute;
• Ability and acceptance to provide written informed consent;
• Willing and able to comply with study requirements and restrictions;
• Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis.

Exclusion Criteria:

• Past or present history of atopy (atopic dermatitis problems, urticaria, asthma or allergic rhinitis) with no ascertained intolerance to histamine;
• Past or present skin disease;
• Lesions or any skin changes in the forearms in the month prior to the Screening Visit;
• History of neurological diseases;
• Past or present pain-related diseases such as cluster headaches, migraine, or back pain;
• Treatment with all topical cream and ointments including cosmetics applied on the forearm in the 10 days prior to the screening visit;
• Participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
• Exposure (within 2 weeks of the Baseline Visit) to any prescription medication or over-the-counter medication including dietary supplements and/or herbal remedies, except those listed on Section 8.2;
• Exposure (within 4 weeks of the Screening Visit) to any antihistamines, anxiolytics, antidepressants, pain killers including triptanes, neuroleptics, or sleep medications;
• Treatment with any medication known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 days preceding the Screening Visit;
• Administration of medications containing corticosteroids or adrenocorticotropic hormone in the three months prior to the Screening Visit;
• Electrocardiogram reading considered outside the normal limits by the investigator (e.g. abnormally prolonged QTc corrected by Fridericia's method > 450 msec in males, on ECG tracing). The following conduction abnormalities may confound QTc analysis and should be avoided if possible: PR > 220 msec, 2nd or 3rd degree AV block, intraventricular conduction delay with QRS > 120 msec, left branch bundle block, right branch bundle block or Wolff-Parkinson-White syndrome;
• Blood donation in the last 3 months or donation of at least 1500 mL blood (including this study) within the last year;
• History of liver disease and/or positive for one or more of the following serological results:
• A positive hepatitis C antibody test (anti-HCV);
• A positive hepatitis B surface antigen (HBsAg);
• A positive HIV test result ;
• Not willing to sign the informed consent or not able to understand completely the study objectives or risks;
• Clinically relevant abnormalities in clinical lab or physical assessments performed at the screening visit;
• Lack of sensitivity to Substance P and histamine or sensitivity to saline at the Screening Visit;
• Any other sound medical reason as determined by the clinical Investigator.
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>2 drinks/day for males, defined according to USDA Dietary Guidelines 2010), caffeine (>5 cups coffee/tea/day), smokers;
• Diet: abnormal diets (<1600 or >3500 calories/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.