PruritusPhase 1NCT01919944
Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P
A Phase 1 study testing VLY-686 in people with Pruritus, run by Vanda Pharmaceuticals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- VLY-686
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pruritus
- Being tested
- VLY-686, Placebo
- Keywords
- itch
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLY-686Drug
capsules containing either 10 mg or 50 mg VLY-686
PlaceboDrug
Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| VLY-686 20 mg | Experimental | Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules Receives: 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 Receives: 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 Receives: Drug: VLY-686 |
| Placebo | Placebo comparator | Single dose, placebo, administered as either two 10 mg oral capsules or two 50 mg oral capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itch severity score on the Verbal Rating Scale
Measured: 20 minutes after Substance P injection
Itch severity score on the Visual Analog Scale
Measured: 20 minutes after Substance P injection
Secondary outcomes (5)
Dose response of VLY-686 and reduction of itch severity
Measured: 20 minutes after substance P injection
Number of adverse events in subjects taking VLY-686
Measured: 24 hours after Substance P injection
Size of injection site erythema
Measured: 1-20 minutes after Substance P injection
Number of adverse events in subjects taking placebo
Measured: 20 minutes after Substance P inection
Size of injection site and urticaria
Measured: 20 minutes after Substance P injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, Cross Research SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919944
- Sponsor's protocol ID
- VP-VLY-686-1101
- Status last verified
- Jun 2015
- First submitted
- 2 Aug 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01919944
- Acronym / sponsor ID
- VP-VLY-686-1101
- Conditions
- Pruritus
- Keywords
- itch
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VLY-686 20 mg | Experimental | Drug: VLY-686Single dose, 20 mg VLY-686, administered as two 10 mg VLY-686 oral capsules |
| VLY-686 50 mg | Experimental | Drug: VLY-686, Drug: PlaceboSingle 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 |
| VLY-686 100 mg | Experimental | Drug: VLY-686Single dose, 100 mg VLY-686, administered as two 50 mg VLY-686 oral capsules |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose, placebo, administered as either two 10 mg oral capsules or two 50 mg oral capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLY-686capsules containing either 10 mg or 50 mg VLY-686 | Drug | VLY-686 100 mg, VLY-686 20 mg, VLY-686 50 mg |
| PlaceboSugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule | Drug | Placebo, VLY-686 50 mg |
Primary outcome
Itch severity score on the Verbal Rating Scale
Time frame: 20 minutes after Substance P injection
Itch severity score on the Visual Analog Scale
Time frame: 20 minutes after Substance P injection
5 secondary outcomes
Dose response of VLY-686 and reduction of itch severity
Time frame: 20 minutes after substance P injection
Number of adverse events in subjects taking VLY-686
Time frame: 24 hours after Substance P injection
Size of injection site erythema
Time frame: 1-20 minutes after Substance P injection
Number of adverse events in subjects taking placebo
Time frame: 20 minutes after Substance P inection
Size of injection site and urticaria
Time frame: 20 minutes after Substance P injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milko Radicioni, MD principal investigator
Cross Research SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLY-686 in people with Pruritus, run by Vanda Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itch severity score on the Verbal Rating Scale (time frame: 20 minutes after Substance P injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.