PsoriasisPhase 1NCT03201978

A Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of GSK2894512 in Healthy Adult Subjects

A Phase 1 study testing GSK2894512 1% CREAM in people with Psoriasis, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Psoriasis
What is being tested?: GSK2894512 1% CREAM
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 14 Dec 2017to 15 May 2018
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

A history of ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
A history or presence of skin disorders (e.g., irritant contact dermatitis); history or presence of hypertrophic scarring tissue or keloid formation in scars or needle puncture sites; a tattoo, body piercing or branding located on the study medication application site; excessive body hair that in the Investigator's opinion, may interfere with the areas designated for study medication application.
Presence or history of AD or PSO.
Presence of erosions, lacerations, abrasions, dermatitis or any other lesion on the lower legs that could increase absorption of GSK2894512.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Subject has a history of hyperhidrosis.

Show all 19Show fewer

Subject had a major surgery within 8 weeks prior to Baseline (Day -1) or has a major surgery planned during the study.
Known hypersensitivity to GSK2894512 or excipients of the study treatments, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation.
Abnormal aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin values at screening
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody test results at screening.
Presence of out-of-range cardiac interval (PR <110 millisecond (msec), PR >220 msec, QRS <60msec, QRS >119msec and QTcF > 450msec) on the screening ECG (average of the triplicate ECG) or other clinically significant ECG abnormalities.
Any history of latent or active tuberculosis (TB) and/or prophylaxis for tuberculosis according to the TB Medical History screening questionnaire.
Subjects who took an investigational product (in another clinical trial) in the previous 30 days before day 1 of this study.
Use of any medicated topical product on the same areas as study medication applications within 2 weeks prior to admission to clinical research center (CRC) on Day -1 and throughout each inpatient treatment period.
Use of any topical products (apart from medicated topical products), except soap and gentle cleansers (example, moisturizers), on the same areas as study medication applications within 2 days prior to admission to CRC on Day -1 and throughout each inpatient treatment period.
Positive findings of urine drug screen (example, amphetamine, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates, and phencyclidine [PCP]).
Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Subjects who have already participated in this clinical study.
Subjects who donated 50 milliliter (mL) or more of blood in the previous 30 days before day 1 of this study. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 60 days before Day 1 of this study.

About this study

Official title: A Randomized, Double-Blind, Vehicle-Controlled, 3-Period, Sequential Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeat Topical Applications of GSK2894512 Cream in Healthy Adult Participants

GSK2894512 (trans-isomer) is a fully synthetic, non-steroidal anti-inflammatory agent. This study is being conducted to evaluate the PK, safety and tolerability of GSK2894512 cream, 1 percent administered topically to healthy adult subjects. PK parameters obtained in this study will be used to support the design of future maximum use PK (MUPK) studies in subjects with atopic dermatitis (AD) and plaque psoriasis or psoriasis (PSO). This is a phase 1, randomized, double-blind, vehicle-controlled, 3-period, sequential, inpatient study consists of a Screening visit, 3 treatment periods and a follow-up visit. GSK2894512 cream, 1 percent (or matching vehicle) will be administered sequentially in the treatment periods. Period 1 will include once daily repeated topical applications on approximately 5000 centimeter (cm) ^2 intact non-occluded skin area for 21 days. Period 2 will include once daily repeated topical applications on approximately 5000 cm^2 intact occluded skin area for 21 days. Period 3 will include a single topical application on up to 400 cm^2 gently taped-stripped skin area. Each treatment regimen will be followed by washout period for approximately 21 days, except for Treatment Period 3. Approximately 26 healthy adult subjects will be enrolled in to the study. Total duration of participation in this study will be approximately 18 weeks.

Conditions: Psoriasis
Being tested: GSK2894512 1% CREAM, GSK2894512 MATCHING VEHICLE CREAM
Keywords: Healthy adults, GSK2894512, Topical, Psoriasis, Pharmacokinetics
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2894512 1% CREAMDrug
It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.
GSK2894512 MATCHING VEHICLE CREAMDrug
It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.

Study groups in NCT03201978
Study group	Role	What they receive
GSK2894512 cream group	Experimental	Subjects will receive once daily topical repeated application on approximately 5000 cm^2 intact non-occluded skin for 21 days in period 1 followed by once daily on 5000 cm^2 intact occluded skin for 21 days in period 2 (after approximately 21 days of washout period), followed by a single topical application on up to 400 cm^2 gently tape stripped skin area in period 3. Receives: Drug: GSK2894512 1% CREAM
Vehicle cream group	Placebo comparator	Subjects will receive once daily topical repeated application on approximately 5000 cm^2 intact non-occluded skin for 21 days in period 1 followed by once daily on 5000 cm^2 intact occluded skin for 21 days in period 2 (after approximately 21 days of washout period), followed by a single topical application on up to 400 cm^2 gently tape stripped skin area in period 3. Receives: Drug: GSK2894512 MATCHING VEHICLE CREAM

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma concentrations of GSK2894512 (trans-isomer)
Blood samples will be collected at the indicated time points to evaluate plasma concentration of GSK2894512 (trans-isomer).
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUC [0-tau]) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC [0-t) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Maximum observed serum concentration (Cmax) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Time of maximum concentration observed (tmax) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Apparent terminal phase half life (t1/2) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Trough concentration at the end of the dosing interval (Ctau) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Accumulation ratio (Ro) of GSK2894512
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Measured: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours

Secondary outcomes (7)

Number of subjects with any adverse events (AEs) and serious AEs (SAEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other important medical events judged by physician that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Measured: Up to 14 weeks
Number of subjects with abnormal vital sign findings
Vital sign parameters including systolic and diastolic blood pressure, heart rate (HR) and body temperature will be evaluated. Vital sign measurements will be preceded by at least 5 minutes of rest (supine or seated) for the subject in a quiet setting.
Measured: Up to 13 weeks
Number of subjects with abnormal electrocardiogram (ECG) findings
Triplicate 12-lead ECG will be obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF) intervals on Days -1, 3, 9, 16 and 23 in Period-1 and 2; and on Days -1 and 3 in Period-3.
Measured: Up to 13 weeks
Number of subjects with abnormal findings in digital holter monitoring
Continuous digital 12-lead ECGs will be recorded using 12-lead Holter/12-lead ECG recorder from 1 hour prior to dosing to 24 hours after dosing on Days 1, 2, 7, 8, 14, 15, 21 and 22 in period-1 and 2; and on Days 1 and 2 in Period-3.
Measured: Up to 13 weeks
Number of subjects with abnormal findings in physical examination
Complete physical examination will include review of head and neck, heart, lungs, abdomen, skin, general appearance, height and weight.
Measured: Up to 13 weeks
Number of subjects with abnormal clinical laboratory findings
Serum chemistry, hematological and urine analysis parameters will be evaluated.
Measured: Up to 13 weeks
Assessment of degree of local irritation as a measure of local tolerability
Dermal reactions like erythema, edema, papules at test sites will be visually assessed. Degree of local irritation will be assessed to determine tolerability of topical application of GSK2894512 cream. if a subject is found to meet a dermal response graded 4 (definite edema) and above indicated in Erythema and Dermal Response Grading Scale, the study medication applications will be discontinued. Grade <4 will be recorded as an AE.
Measured: Up to 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 201715 May 2018

First posted28 Jun 2017
Study start14 Dec 2017 (estimated)
Primary completion15 May 2018 (estimated)
Study completion15 May 2018 (estimated)

Why it stopped: The whole project was discontinued within GSK, hence this study was cancelled before enrolment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03201978
Sponsor's protocol ID: 207539
Status last verified: Nov 2017
First submitted: 27 Jun 2017
Last updated: 29 Nov 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Vehicle-Controlled, 3-Period, Sequential Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeat Topical Applications of GSK2894512 Cream in Healthy Adult Participants
ClinicalTrials.gov ID: NCT03201978
Acronym / sponsor ID: 207539
Conditions: Psoriasis
Keywords: Healthy adults, GSK2894512, Topical, Psoriasis, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The whole project was discontinued within GSK, hence this study was cancelled before enrolment.
Enrolment: 0 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: iCardiac Technologies, Inc., Innovaderm Research Inc., PPD Development, LP, Algorithme
Study start: 14 Dec 2017 (estimated)
Primary completion: 15 May 2018 (estimated)
Study completion: 15 May 2018 (estimated)
First posted: 28 Jun 2017 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
GSK2894512 cream group	Experimental	Drug: GSK2894512 1% CREAMSubjects will receive once daily topical repeated application on approximately 5000 cm^2 intact non-occluded skin for 21 days in period 1 followed by once daily on 5000 cm^2 intact occluded skin for 21 days in period 2 (after approximately 21 days of washout period), followed by a single topical application on up to 400 cm^2 gently tape stripped skin area in period 3.
Vehicle cream group	Placebo comparator	Drug: GSK2894512 MATCHING VEHICLE CREAMSubjects will receive once daily topical repeated application on approximately 5000 cm^2 intact non-occluded skin for 21 days in period 1 followed by once daily on 5000 cm^2 intact occluded skin for 21 days in period 2 (after approximately 21 days of washout period), followed by a single topical application on up to 400 cm^2 gently tape stripped skin area in period 3.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (19 listed)

A history of ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
A history or presence of skin disorders (e.g., irritant contact dermatitis); history or presence of hypertrophic scarring tissue or keloid formation in scars or needle puncture sites; a tattoo, body piercing or branding located on the study medication application site; excessive body hair that in the Investigator's opinion, may interfere with the areas designated for study medication application.
Presence or history of AD or PSO.
Presence of erosions, lacerations, abrasions, dermatitis or any other lesion on the lower legs that could increase absorption of GSK2894512.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

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
GSK2894512 1% CREAMIt will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.	Drug	GSK2894512 cream group
GSK2894512 MATCHING VEHICLE CREAMIt will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.	Drug	Vehicle cream group

Primary outcome

Plasma concentrations of GSK2894512 (trans-isomer)
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood samples will be collected at the indicated time points to evaluate plasma concentration of GSK2894512 (trans-isomer).
Area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUC [0-tau]) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC [0-t) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Maximum observed serum concentration (Cmax) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Time of maximum concentration observed (tmax) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Apparent terminal phase half life (t1/2) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Trough concentration at the end of the dosing interval (Ctau) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.
Accumulation ratio (Ro) of GSK2894512
Time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours
Blood sample will be collected at the indicated time points to evaluate PK profile of GSK2894512.

7 secondary outcomes

Number of subjects with any adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 14 weeks
Number of subjects with abnormal vital sign findings
Time frame: Up to 13 weeks
Number of subjects with abnormal electrocardiogram (ECG) findings
Time frame: Up to 13 weeks
Number of subjects with abnormal findings in digital holter monitoring
Time frame: Up to 13 weeks
Number of subjects with abnormal findings in physical examination
Time frame: Up to 13 weeks
Number of subjects with abnormal clinical laboratory findings
Time frame: Up to 13 weeks
Assessment of degree of local irritation as a measure of local tolerability
Time frame: Up to 14 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.

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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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2894512 1% CREAM in people with Psoriasis, run by GlaxoSmithKline.

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 0 inclusion and 19 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: withdrawn, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Plasma concentrations of GSK2894512 (trans-isomer) (time frame: Days 1, 7, 14, 21: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16 hours; Days 2, 3, 8, 9, 15, 16, 22, 23: Pre-dose, in Period-1 and 2. Period-3: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48 hours). The study lists 8 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 NCT03201978.

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 29 Nov 2017.