Histamine Induced ItchPhase 1NCT01068223
A Study To Investigate The Effect of JNJ-39758979 on Histamine Induced Itch in Healthy Male Volunteers
A Phase 1 study of Histamine Induced Itch, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on histamine induced itch in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Histamine Induced Itch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to May 2010
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker or ex-smoker for at least 3 months
- Should generally be in good health
- Must have negative urine alcohol and drug tests
- Must consent to utilize a medically acceptable method of contraception throughout the study and for three months after the last dose of study drug and not donate sperm during the study and for 3 months after receiving the last dose of study drug
Who cannot join
- Positive for hepatitis B, hepatitis C, or HIV
- History of drug or alcohol abuse within the past two years
- Known allergies, hypersensitivity, or intolerance to cetirizine (Zyrtec)
- Any confirmed significant reactions against any drug
- Active skin diseases
- History of atopic disease or evidence of allergen sensitization by skin prick testing to common aeroallergens
- Use of antihistamines or antidepressants with antihistamine properties within the last 7 days, prescription medication within the last 14 days or Monoamine oxidase inhibitors (MAOIs) within the last 21 days
- Have received an investigational drug or device within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Single-Dose, Double-Blind, Modified-Double-Dummy, Placebo and Active-Controlled, Randomized, Three-Way, Six-Sequence Cross-Over Study to Investigate the Effect of JNJ-39758979 on Histamine Induced Pruritus in Healthy Male Subjects
The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on histamine induced itch in healthy male volunteers.
Read the detailed description
The goal of this study is to evaluate the effect and safety of a single oral dose of JNJ-39758979 on histamine-induced itch and hive in 24 healthy male volunteers. This is a three-treatment, double-blind (neither the volunteer nor the study physician will know the identity of the treatment), cross-over (each volunteer receives all three treatments) study. The study is also randomized, meaning that the order in which treatments are given is determined randomly (by chance, like flipping a coin). The total participation time is approximately 8 to 9 weeks, which includes a screening visit, three treatment periods, two wash-out periods (breaks), and a follow-up visit after the third treatment period. All three treatment periods require a 2-day stay in the clinic. Volunteers will have a histamine test at the screening visit and three times during each treatment period (total of 10 tests). The histamine test consists of an injection of a small amount of histamine solution into the upper layer of the skin, which may cause itchiness, a flare response (redness on the skin) and wheal response (elevated bump in the skin) lasting for 30 to 60 minutes. Volunteers will be blindfolded during the procedure and asked to rate the severity of the itch. The areas of the wheal and flare will be measured by a laser scanner, which will not cause harm to the volunteer. During the treatment periods, volunteers will receive the histamine test on the day before study drug and/or placebo is given and at 2 and 6 hours after study drug and/or placebo is given. During the study, safety evaluations, which will include ECGs (a cardiac function test) and vital signs, will be performed, and side effects will be monitored. Blood and urine samples will be collected at the screening visit, during the first day of each treatment period in the clinic and at the follow-up visit for evaluation. Volunteers will receive single doses of 600mg JNJ-39758979, placebo, and 10mg cetirizine in random order over three treatment periods. The first two treatment periods will be followed by an approximately 14 day wash-out period.
- Conditions
- Histamine Induced Itch
- Being tested
- A:JNJ-39758979/Placebo #1, C:Cetirizine/JNJ-39758979 Matching Placebo, B: JNJ-39758979 Matching Placebo /Placebo #2
- Keywords
- Cetirizine, CR016609
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A:JNJ-39758979/Placebo #1Drug
Single oral dose of JNJ-39758979 600 mg and Placebo
C:Cetirizine/JNJ-39758979 Matching PlaceboDrug
JNJ-39758979 Matching Placebo and Placebo #2
B: JNJ-39758979 Matching Placebo /Placebo #2Drug
A single dose of 2 different Placebos
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | A:JNJ-39758979/Placebo #1 Single oral dose of JNJ-39758979 600 mg and Placebo Receives: Drug: A:JNJ-39758979/Placebo #1 |
| 002 | Placebo comparator | B: JNJ-39758979 Matching Placebo /Placebo #2 A single dose of 2 different Placebos JNJ-39758979 Matching Placebo and Placebo #2 Receives: Drug: B: JNJ-39758979 Matching Placebo /Placebo #2 |
| 003 | Active comparator | C:Cetirizine/JNJ-39758979 Matching Placebo Single oral dose of 10mg cetirizine and JNJ-39758979 Matching Placebo Receives: Drug: C:Cetirizine/JNJ-39758979 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-assessed pruritis score following histamine challenge
Measured: at 30 second intervals for the first 5 minutes and then at 1 minute intervals through 10 minutes
Secondary outcomes (1)
To evaluate the effect of single oral dose of JNJ-39758979 (600mg) on histamine-induced wheal and flare in healthy volunteers
Measured: at 10 minutes following histamine challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histamine Induced ItchStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068223
- Sponsor's protocol ID
- CR016609
- Status last verified
- Sep 2013
- First submitted
- 11 Feb 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Dose, Double-Blind, Modified-Double-Dummy, Placebo and Active-Controlled, Randomized, Three-Way, Six-Sequence Cross-Over Study to Investigate the Effect of JNJ-39758979 on Histamine Induced Pruritus in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01068223
- Acronym / sponsor ID
- CR016609
- Conditions
- Histamine Induced Itch
- Keywords
- Cetirizine, CR016609
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Study completion
- May 2010 (actual)
- First posted
- 12 Feb 2010 (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 investigate the effect of JNJ-39758979 compared to placebo on histamine induced itch in healthy male volunteers.
Detailed description
The goal of this study is to evaluate the effect and safety of a single oral dose of JNJ-39758979 on histamine-induced itch and hive in 24 healthy male volunteers. This is a three-treatment, double-blind (neither the volunteer nor the study physician will know the identity of the treatment), cross-over (each volunteer receives all three treatments) study. The study is also randomized, meaning that the order in which treatments are given is determined randomly (by chance, like flipping a coin). The total participation time is approximately 8 to 9 weeks, which includes a screening visit, three treatment periods, two wash-out periods (breaks), and a follow-up visit after the third treatment period. All three treatment periods require a 2-day stay in the clinic. Volunteers will have a histamine test at the screening visit and three times during each treatment period (total of 10 tests). The histamine test consists of an injection of a small amount of histamine solution into the upper layer of the skin, which may cause itchiness, a flare response (redness on the skin) and wheal response (elevated bump in the skin) lasting for 30 to 60 minutes. Volunteers will be blindfolded during the procedure and asked to rate the severity of the itch. The areas of the wheal and flare will be measured by a laser scanner, which will not cause harm to the volunteer. During the treatment periods, volunteers will receive the histamine test on the day before study drug and/or placebo is given and at 2 and 6 hours after study drug and/or placebo is given. During the study, safety evaluations, which will include ECGs (a cardiac function test) and vital signs, will be performed, and side effects will be monitored. Blood and urine samples will be collected at the screening visit, during the first day of each treatment period in the clinic and at the follow-up visit for evaluation. Volunteers will receive single doses of 600mg JNJ-39758979, placebo, and 10mg cetirizine in random order over three treatment periods. The first two treatment periods will be followed by an approximately 14 day wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: A:JNJ-39758979/Placebo #1A:JNJ-39758979/Placebo #1 Single oral dose of JNJ-39758979 600 mg and Placebo |
| 002 | Placebo comparator | Drug: B: JNJ-39758979 Matching Placebo /Placebo #2B: JNJ-39758979 Matching Placebo /Placebo #2 A single dose of 2 different Placebos JNJ-39758979 Matching Placebo and Placebo #2 |
| 003 | Active comparator | Drug: C:Cetirizine/JNJ-39758979 Matching PlaceboC:Cetirizine/JNJ-39758979 Matching Placebo Single oral dose of 10mg cetirizine and JNJ-39758979 Matching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoker or ex-smoker for at least 3 months
- Should generally be in good health
- Must have negative urine alcohol and drug tests
- Must consent to utilize a medically acceptable method of contraception throughout the study and for three months after the last dose of study drug and not donate sperm during the study and for 3 months after receiving the last dose of study drug
Key exclusion criteria (8 listed)
- Positive for hepatitis B, hepatitis C, or HIV
- History of drug or alcohol abuse within the past two years
- Known allergies, hypersensitivity, or intolerance to cetirizine (Zyrtec)
- Any confirmed significant reactions against any drug
- Active skin diseases
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 |
|---|---|---|
| A:JNJ-39758979/Placebo #1Single oral dose of JNJ-39758979 600 mg and Placebo | Drug | 001 |
| C:Cetirizine/JNJ-39758979 Matching PlaceboJNJ-39758979 Matching Placebo and Placebo #2 | Drug | 003 |
| B: JNJ-39758979 Matching Placebo /Placebo #2A single dose of 2 different Placebos | Drug | 002 |
Primary outcome
Participant-assessed pruritis score following histamine challenge
Time frame: at 30 second intervals for the first 5 minutes and then at 1 minute intervals through 10 minutes
1 secondary outcome
To evaluate the effect of single oral dose of JNJ-39758979 (600mg) on histamine-induced wheal and flare in healthy volunteers
Time frame: at 10 minutes following histamine challenge
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 4 Sep 2013.
Related trials for Histamine Induced Itch
Recruiting
Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation)
Histamine, Cowhage
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 of Histamine Induced Itch, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United Kingdom.
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 4 inclusion and 8 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 4 Sep 2013. 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 United Kingdom. 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?
Participant-assessed pruritis score following histamine challenge (time frame: at 30 second intervals for the first 5 minutes and then at 1 minute intervals through 10 minutes). 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 4 Sep 2013.