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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Arzo, Switzerland, CH 6864
        • Vanda Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VLY-686 20 mg
Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules
Drug: VLY-686
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
Drug: VLY-686
capsules containing either 10 mg or 50 mg VLY-686
Drug: Placebo
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
Drug: VLY-686
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
Drug: Placebo
Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Itch severity score on the Verbal Rating Scale
Time Frame: 20 minutes after Substance P injection
20 minutes after Substance P injection
Itch severity score on the Visual Analog Scale
Time Frame: 20 minutes after Substance P injection
20 minutes after Substance P injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dose response of VLY-686 and reduction of itch severity
Time Frame: 20 minutes after substance P injection
20 minutes after substance P injection
Number of adverse events in subjects taking VLY-686
Time Frame: 24 hours after Substance P injection
24 hours after Substance P injection
Size of injection site erythema
Time Frame: 1-20 minutes after Substance P injection
1-20 minutes after Substance P injection
Number of adverse events in subjects taking placebo
Time Frame: 20 minutes after Substance P inection
20 minutes after Substance P inection
Size of injection site and urticaria
Time Frame: 20 minutes after Substance P injection
20 minutes after Substance P injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanda Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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