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

NCT01919944 | Completed Phase 1

• 1 other identifier: VP-VLY-686-1101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 placebo.

Conditions

Pruritus

Keywords

itch

Outcome Measures

Primary Outcomes (2)

• Itch severity score on the Verbal Rating Scale

  20 minutes after Substance P injection

• Itch severity score on the Visual Analog Scale

  20 minutes after Substance P injection

Secondary Outcomes (5)

• Dose response of VLY-686 and reduction of itch severity

  20 minutes after substance P injection

• Number of adverse events in subjects taking VLY-686

  24 hours after Substance P injection

• Size of injection site erythema

  1-20 minutes after Substance P injection

• Number of adverse events in subjects taking placebo

  20 minutes after Substance P inection

• Size of injection site and urticaria

  20 minutes after Substance P injection

Study Arms (4)

VLY-686 20 mg

EXPERIMENTAL

Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules

Drug: VLY-686

VLY-686 50 mg

EXPERIMENTAL

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; Drug: Placebo

VLY-686 100 mg

EXPERIMENTAL

Single dose, 100 mg VLY-686, administered as two 50 mg VLY-686 oral capsules

Drug: VLY-686

Placebo

PLACEBO COMPARATOR

Single dose, placebo, administered as either two 10 mg oral capsules or two 50 mg oral capsules

Drug: Placebo

Interventions

VLY-686 DRUG

capsules containing either 10 mg or 50 mg VLY-686

VLY-686 100 mg; VLY-686 20 mg; VLY-686 50 mg

Placebo DRUG

Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule

Placebo; VLY-686 50 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Vanda Investigational Site

Arzo, CH 6864, Switzerland

Location

MeSH Terms

Conditions

Pruritus

Interventions

LY686017

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Milko Radicioni, MD

  Cross Research SA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

CH (1)