Dermatitis, AtopicPhase 1NCT01673529
Investigation of Topical SB705498 on Healthy Volunteers
A Phase 1 study testing SB705498 in people with Dermatitis, Atopic, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- SB705498
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2012to 4 Oct 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Caucasian volunteers aged between 18 and 65 years of age inclusive, at time of signing the informed consent. Healthy subjects are defined as individuals who are not taking any regular medication and are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, 12-lead ECG, laboratory studies, and other tests specified in this protocol.
- Subject has the ability to read, comprehend, and record information required by protocol, and is willing and able to provide signed and dated written informed consent prior to study participation, including compliance with the requirements and restrictions listed in the consent form.
- Non smoker who has not smoked or used nicotine containing products for a minimum period of 6 months prior to the screening visit.
- Subject must score greater than 40 on a COVAS scale of 0-100 for itch induced by both cowhage and histamine at screening and show a flare response with capsaicin measured by LDI scan.
- Is willing to avoid UV exposure. i.e. use of Sun beds and sunbathing for 7 days prior to screening, throughout the study and and until a week after the last dose. Subjects who require treatment with photosensitizing drugs (e.g, tetracycline, thiazides, fluoroquinolones, phenothiazines, or sulfonamides) will withdrawn. Subjects must also be willing to use sunscreen of SPF30 or above on the volar surface of the forearms for a week after the last dose.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol if they wish to continue their HRT during the study.
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- Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]; Child-bearing potential and agrees to use one of the contraception methods listed in the protocol. Female subjects willing to participate in the study must agree to use contraception from the screening visit until 15 days post-last treatment administration.
- Male subjects must agree to use one of the contraception methods listed in the protocol. For male subjects willing to participate in the study this criterion must be followed from the time of the screening visit until 15 days post-last treatment
- BMI within the range 19.0 - 32.0 kg/m2 (inclusive).
- AST and ALT less than 2xULN; alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin.
- QTcB or QTcF less than 450 msec. Note that if the initial QTc value is prolonged, the ECG should be repeated two more times (with 5 minutes between ECG readings) and the average of the three QTc values used to determine eligibility.
Who cannot join
- Suffers from skin infection or inflammation of the forearm, or has other arm skin irregularities that may in the opinion of the investigator interfere with study assessments (e.g. nevi, tattoos).
- The subject suffers from eczema, psoriasis or any other acute or chronic dermatological problem if, in the opinion of the investigator this is likely to interfere with study assessments
- Any subject with localised sunburn in the area to be treated as part of the study.
- History of regular alcohol/drug consumption within 6 months of the study. Regular alcohol consumption defined as: an average weekly intake of greater than 21 units for males and greater than 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, one glass (125 ml) of wine or one (25 ml) measure of spirits.
- A positive pre-study drug/alcohol screen at screening visit. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- The subject has participated in a clinical trial resulting in exposure to more than four new chemical entities within 12 months prior to the first dosing day or has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Unable to refrain from use of prescription or non-prescription drugs. Refer to the protocol for details.
- History of sensitivity to any of the study medications SB705498, challenge agents or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period following completion of the study.
- Lactating females.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody.
- Excessive caffeine drinkers (approximately 5 or more cups a day) or the subject is unable to commit to refraining from caffeine-containing products for 24hrs prior to each assessment visit and whilst present in the unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.
A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers.
Read the detailed description
This study is a two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in healthy volunteers. Part A has been designed to establish whether the topical formulation is capable of delivering SB705498 to the proposed site of action, and to select an appropriate dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a histaminergic and a non-histaminergic pathway, using two different challenge agents; histamine and cowhage. This may provide important information about the role of TRPV1 in pruritus and the therapeutic potential of SB705498.
- Conditions
- Dermatitis, Atopic
- Being tested
- SB705498, Placebo
- Keywords
- Pruritus, TRPV1, Cowhage, Atopic Dermatitis, Capsaicin, Itch, Histamine, healthy volunteers, SB705498, Clinical
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB705498Drug
1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.
PlaceboDrug
Placebo to match SB705498 will be used in both Part A and Part B of the study.
| Study group | Role | What they receive |
|---|---|---|
| study population | Experimental | All subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator Receives: Drug: SB705498; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the area of flare induced by capsaicin as assessed by Laser
Measured: 1 hour
2) Average itch over maximum of 15 minutes post application of challenge agent
Measured: 15 minutes
Secondary outcomes (2)
vital sign measurements, ECG, Clinical Laboratory data and Adverse Events
safety and tolerability
Measured: 3 months
Peak itch intensity on 0 to 100 COVAS (Computerised visual analogue scale)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study start17 Jul 2012
- Primary completion4 Oct 2012
- Study completion4 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673529
- Sponsor's protocol ID
- 115246
- Status last verified
- Jun 2017
- First submitted
- 12 Jul 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Gibson RA, Robertson J, Mistry H, McCallum S, Fernando D, Wyres M, Yosipovitch G. A randomised trial evaluating the effects of the TRPV1 antagonist SB705498 on pruritus induced by histamine, and cowhage challenge in healthy volunteers. PLoS One. 2014 Jul 21;9(7):e100610. doi: 10.1371/journal.pone.0100610. eCollection 2014.
PubMed 25047038
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01673529
- Acronym / sponsor ID
- 115246
- Conditions
- Dermatitis, Atopic
- Keywords
- Pruritus, TRPV1, Cowhage, Atopic Dermatitis, Capsaicin, Itch, Histamine, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2012 (actual)
- Primary completion
- 4 Oct 2012 (actual)
- Study completion
- 4 Oct 2012 (actual)
- First posted
- 28 Aug 2012 (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.
A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers.
Detailed description
This study is a two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in healthy volunteers. Part A has been designed to establish whether the topical formulation is capable of delivering SB705498 to the proposed site of action, and to select an appropriate dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a histaminergic and a non-histaminergic pathway, using two different challenge agents; histamine and cowhage. This may provide important information about the role of TRPV1 in pruritus and the therapeutic potential of SB705498.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | Experimental | Drug: SB705498, Drug: PlaceboAll subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy Caucasian volunteers aged between 18 and 65 years of age inclusive, at time of signing the informed consent. Healthy subjects are defined as individuals who are not taking any regular medication and are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, 12-lead ECG, laboratory studies, and other tests specified in this protocol.
- Subject has the ability to read, comprehend, and record information required by protocol, and is willing and able to provide signed and dated written informed consent prior to study participation, including compliance with the requirements and restrictions listed in the consent form.
- Non smoker who has not smoked or used nicotine containing products for a minimum period of 6 months prior to the screening visit.
- Subject must score greater than 40 on a COVAS scale of 0-100 for itch induced by both cowhage and histamine at screening and show a flare response with capsaicin measured by LDI scan.
- Is willing to avoid UV exposure. i.e. use of Sun beds and sunbathing for 7 days prior to screening, throughout the study and and until a week after the last dose. Subjects who require treatment with photosensitizing drugs (e.g, tetracycline, thiazides, fluoroquinolones, phenothiazines, or sulfonamides) will withdrawn. Subjects must also be willing to use sunscreen of SPF30 or above on the volar surface of the forearms for a week after the last dose.
Key exclusion criteria (13 listed)
- Suffers from skin infection or inflammation of the forearm, or has other arm skin irregularities that may in the opinion of the investigator interfere with study assessments (e.g. nevi, tattoos).
- The subject suffers from eczema, psoriasis or any other acute or chronic dermatological problem if, in the opinion of the investigator this is likely to interfere with study assessments
- Any subject with localised sunburn in the area to be treated as part of the study.
- History of regular alcohol/drug consumption within 6 months of the study. Regular alcohol consumption defined as: an average weekly intake of greater than 21 units for males and greater than 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, one glass (125 ml) of wine or one (25 ml) measure of spirits.
- A positive pre-study drug/alcohol screen at screening visit. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
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 |
|---|---|---|
| SB7054981%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study. | Drug | study population |
| PlaceboPlacebo to match SB705498 will be used in both Part A and Part B of the study. | Drug | study population |
Primary outcome
Measurement of the area of flare induced by capsaicin as assessed by Laser
Time frame: 1 hour
2) Average itch over maximum of 15 minutes post application of challenge agent
Time frame: 15 minutes
2 secondary outcomes
vital sign measurements, ECG, Clinical Laboratory data and Adverse Events
Time frame: 3 months
Peak itch intensity on 0 to 100 COVAS (Computerised visual analogue scale)
Time frame: 15 minutes
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 9 Jun 2017.
- Derived from this study: PubMed 25047038Gibson RA, Robertson J, Mistry H, McCallum S, Fernando D, Wyres M, Yosipovitch G. A randomised trial evaluating the effects of the TRPV1 antagonist SB705498 on pruritus induced by histamine, and cowhage challenge in healthy volunteers. PLoS One. 2014 Jul 21;9(7):e100610. doi: 10.1371/journal.pone.0100610. eCollection 2014.
- Results for study 115246 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 SB705498 in people with Dermatitis, Atopic, run by GlaxoSmithKline 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 11 inclusion and 13 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 9 Jun 2017. 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. 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?
Measurement of the area of flare induced by capsaicin as assessed by Laser (time frame: 1 hour). 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?
On the ClinicalTrials.gov record for NCT01673529, which also lists 1 linked publication.
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 9 Jun 2017.