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NCT04676763 | Completed | Skin Diseases


Substance P Challenge in Healthy Participants
Sponsor:

GlaxoSmithKline

Brief Summary:

The objectives of this enabling study are to characterize the wheal and flare responses over time following skin challenges with ascending concentrations of Substance P. This will be a 2-part study: Part 1 will aid in the understanding of the wheal and flare responses following Substance P. Part 2 will investigate the variability of the responses. Participants may be enrolled into Part 1 or Part 2, not both.

Condition or disease

Skin Diseases

Intervention/treatment

Substance P

Normal Saline

Histamine

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 37 participants
Masking: None (Open Label)
Masking Description: It is an open-label study.
Primary Purpose: Other
Official Title: An Open Label, Single Centre, Enabling Study to Investigate the Optimum Method for Use of Intradermal Substance P as a Challenge Agent in Healthy Participants
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : July 21, 2021
Estimated Study Completion Date : July 21, 2021
Arm Intervention/treatment

Experimental: Substance P challenge in Part 1

Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 1 will include a single challenge visit.

Drug: Substance P

Drug: Normal Saline

Drug: Histamine

Experimental: Substance P challenge in Part 2

Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 2 will include two challenge visits.

Drug: Substance P

Drug: Normal Saline

Drug: Histamine

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion criteria
  • 18 to 50 years of age inclusive.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECGs and vital signs.
  • Participants who responded positive to histamine skin prick test and negative to saline injection at screening.
  • Participants with Fitzpatrick skin type I-II (Caucasian).
  • Body weight greater than or equal to (>=) 50 kilogram (kg) and body mass index (BMI) within the range 19-29.9 kilogram per meter square (kg/m2) (inclusive).
  • Male participants are eligible to participate in the study.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding or using highly effective contraceptive methods. Woman of non-childbearing potential can also participate.
  • A sensitive pregnancy test is required to be negative on the day of each challenge.
  • Capable of giving signed informed consent.
Exclusion Criteria
  • Significant history of or current, cardiovascular (including hypotension, severe hypertension, vasomotor instability), respiratory (including asthma), renal, gastrointestinal, endocrine, hematological, infectious or neurological disorders constituting a risk when taking part in the study or interfering with the interpretation of data.
  • History or presence of significant skin disorder (such as but not limited to chronic urticaria, atopic dermatitis, severe eczema, psoriasis or skin cancer).
  • History of risk for or actual experience of complications from skin biopsy including excess bleeding, infection, or scarring/keloid formation.
  • Abnormal blood pressure as determined by the investigator.
  • Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
  • Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec), based on the mean of triplicate ECGs.
  • Use of any form of H1 or H2 antihistamine, tricyclic antidepressants, beta2 agonists, dopamine, or beta blocking agents within 14 days before the first challenge visit through final assessments.
  • Use of topical medications such as but not limited to retinoids, steroids, and transdermal hormone replacement therapies on or near the intended site of application within 8 weeks prior to dosing through treatment follow up. Use of other topical preparations such as those containing vitamins, supplements or herbal within 2 weeks prior to dosing through treatment follow up.
  • Past or intended use of any other non-topical over-the-counter or prescription medication, including herbal medications, within 7 days before the first challenge visit, unless, in the opinion of the investigator and GlaxoSmithKline medical monitor, the medication will not constitute a risk when taking the study intervention or interfere with the interpretation of data.
  • Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months.
  • Current enrolment in any clinical study involving an investigational study intervention or any other type of medical research.
  • Current enrolment or past participation in this study.
  • Presence of Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) at screening or within 3 months before the first challenge day.
  • Positive Hepatitis C antibody test result at screening or within 3 months before the first challenge day.
  • Positive Hepatitis C RNA test result at screening or within 3 months before the first challenge day.
  • Positive pre-study drug/alcohol screen.
  • Positive human immunodeficiency virus (HIV) antibody test at screening or within 3 months before the first challenge day.
  • Current use of known drugs of abuse.
  • Participants who present with damaged skin including sunburn, scar tissue, moles, uneven skin tones and dark skin tone (Fitzpatrick>2), tattoos, body piercings, branding or other skin disfiguration on or near the intended site of application which could interfere with the assessments
  • Regular alcohol consumption within 6 months before the study defined as an average weekly intake of >21 units for males or >14 units for females.
  • Smoking test result indicative of smoking, history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
  • Unable to refrain from the use of topical medications from before the first to after the last challenge visit.

Substance P Challenge in Healthy Participants

Location Details


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Substance P Challenge in Healthy Participants

How to Participate

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Locations


Not yet recruiting

Netherlands,

GSK Investigational Site

Leiden, Netherlands, 2333 CL

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