- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919944
Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P
June 1, 2015 updated by: Vanda Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Four-Way Crossover Study on Itch Control by VLY-686 Administration in Healthy Volunteers After Intradermal Injections of Substance P
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 placebo.
Study Overview
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 healthy volunteers receiving oral doses of 20 mg, 50 mg or 100 mg VLY-686 or a matching placebo.
Twelve healthy male subjects satisfying the selection criteria for the study will be enrolled.
Each subject will participate in a screening period (up to 21 days prior to dosing), four one-day treatment periods each separated by a 7 (±2 days) day washout period, and an end-of-study evaluation prior to discharge from the study.
This protocol also includes an option of subjects administered daily doses of study medication between Periods 3 and 4. The treatment periods will be in a randomized sequence consisting of 1) 20 mg VLY-686, 2) 50 mg VLY-686, 100 mg VLY-686 and 4) placebo.
In each of the study periods, Substance P will be injected 5 times: pre-dose (the night before), 2, 4, 8 and 12 hours (± 10 minutes) after study medication administration.
A dose of 100 μL of a 2.5 nmol/mL sterile solution of Substance P will be injected each time.
Overall, subjects will be administered 1.25 nmol of Substance P in around 24 hours (5 doses).
Substance P injections will be given in the volar of the forearm, alternating right and left and avoiding injections in an area adjacent to the area previously injected.
The subject's forearm will be covered during and after each injection to avoid potential biases in the scoring of the Verbal Rating Scale (VRS) and Visual Analog Scale (VAS).
Additionally, blood samples for VLY-686 pharmacokinetic (PK) analysis will be collected each period at pre-dose, 1, 3, 6, 10, and 24 hours after study medication administration.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Arzo, Switzerland, CH 6864
- Vanda Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VLY-686 20 mg
Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules
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capsules containing either 10 mg or 50 mg VLY-686
|
Experimental: VLY-686 50 mg
Single dose, 50 mg VLY-686, administered as one 50 mg VLY-686 oral capsule and one placebo capsule mimicking the VLY-686 50 mg capsule
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capsules containing either 10 mg or 50 mg VLY-686
Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule
|
Experimental: VLY-686 100 mg
Single dose, 100 mg VLY-686, administered as two 50 mg VLY-686 oral capsules
|
capsules containing either 10 mg or 50 mg VLY-686
|
Placebo Comparator: Placebo
Single dose, placebo, administered as either two 10 mg oral capsules or two 50 mg oral capsules
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Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Itch severity score on the Verbal Rating Scale
Time Frame: 20 minutes after Substance P injection
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20 minutes after Substance P injection
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Itch severity score on the Visual Analog Scale
Time Frame: 20 minutes after Substance P injection
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20 minutes after Substance P injection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose response of VLY-686 and reduction of itch severity
Time Frame: 20 minutes after substance P injection
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20 minutes after substance P injection
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Number of adverse events in subjects taking VLY-686
Time Frame: 24 hours after Substance P injection
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24 hours after Substance P injection
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Size of injection site erythema
Time Frame: 1-20 minutes after Substance P injection
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1-20 minutes after Substance P injection
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Number of adverse events in subjects taking placebo
Time Frame: 20 minutes after Substance P inection
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20 minutes after Substance P inection
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Size of injection site and urticaria
Time Frame: 20 minutes after Substance P injection
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20 minutes after Substance P injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Milko Radicioni, MD, CROSS Research SA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
August 2, 2013
First Submitted That Met QC Criteria
August 6, 2013
First Posted (Estimate)
August 9, 2013
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP-VLY-686-1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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