Status:
COMPLETED
Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Pruritus
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and dermatological reaction observed after healthy volunteers are injected with Substance P in comparison with place...
Detailed Description
This is a double-blind, randomized, 4-way crossover, pharmacokinetic and pharmacodynamic (PK/PD) study to compare the cutaneous vasoreactive intensity to intradermal injections of Substance P in healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01919944
Start Date
August 1 2013
End Date
November 1 2013
Last Update
June 3 2015
Active Locations (1)
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1
Vanda Investigational Site
Arzo, Switzerland, CH 6864