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First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426995
Recruitment Status : Terminated (The trial was terminated for strategic reasons following the emergence of new data.)
First Posted : February 9, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response. This study will evaluate the safety, tolerability, pharmacokinetic (PK) and PD profile of single (in both fed and fasted states) and multiple ascending doses of GSK3358699 in healthy male subjects within a pre-defined and controlled pharmacodynamic and pharmacokinetic range for each cohort. It also intends to understand the effect of GSK3358699 on systemic markers of inflammation following low dose in vivo lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) challenge and local inflammation in cantharidin-induced blisters. The study has been carefully designed to explore the in vivo biology of the target and the potential for the study drug to become a transformative medicine for subjects in multiple immuno-inflammatory disease indications.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Placebo Drug: GSK3358699 Biological: GM-CSF Biological: LPS Other: Cantharidin Phase 1

Detailed Description:
Subjects who are enrolled in the dose escalation treatment Periods of Part A may choose to only take part in the dose escalation treatment Periods 1-3, or may choose to also take part in the challenge Treatment Period (Period 4). If a subject chooses to participate in the dose escalation treatment Periods 1-3 only, or does not (at screening) meet the eligibility criteria specific to challenges (treatment Period 4), a new subject will be recruited for treatment Period 4 only and will be regarded as a replacement subject. The study will be conducted in three Parts. Total duration for participation will be approximately 19 weeks for subjects taking part in all three dose escalation treatment Periods and 23 weeks if a subject takes part in all four treatment Periods of Part A. For replacement subjects only taking part in the challenge treatment Period (Period 4), approximate study duration will be 10 weeks. Total duration for participation will be approximately 9 weeks for Part B and 12 weeks for Part C. The study will be conducted in up to 80 subjects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Study will be conducted as Part A, B and C. Part A will consist of 2-interlocking cohorts, where each subject will receive maximum 2-single ascending oral doses of GSK3358699 and 1 dose of placebo, in Treatment Periods (TP) 1 to 3. In TP 4 subjects will receive GSK3358699, dose evaluated in TP (1 to 3) or placebo, with cantharidin induced blisters and either LPS or GM-CSF in vivo challenge. Part B will comprise of single cohort taking part in two-way cross over, with open label phase where each subject will receive single oral dose of GSK3358699 (based on Part A), under fed and fasted conditions in each TP. Part C will consist of 3 cohorts with multiple ascending doses, with every cohort having one repeat dose TP with 14 days of daily dosing of either GSK3358699 or placebo. Subjects on Day 14 will receive cantharidin induced blisters with either LPS or GM-CSF in vivo challenge. An optional, cohort 7 may be included for further dose evaluation of GSK3358699 or alternate dosing schedule.
Masking: Double (Participant, Investigator)
Masking Description: This will be a double blind (sponsor open) study with respect to allocation of GSK3358699 or placebo to subjects. All site staff will be blinded with the exception of un-blinded pharmacists. Investigators will be un-blinded with respect to the LPS and GM-CSF allocation. The food effect part of the study (Part B) will be open-label
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind (Sponsor Open), Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699 in Healthy Male Participants
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : May 2, 2019
Actual Study Completion Date : May 2, 2019

Arm Intervention/treatment
Experimental: GSK3358699, Part A, Cohort 1
Part A will comprise of 4 TPs. The subjects in this cohort will receive GSK3358699, as single escalation dose, during TP (1 to 3) with planned escalated doses as 1 mg, 10 mg and 35 mg. Dose of 1 mg will be given as solution and doses of 10 mg and 35 mg, will be given as a capsule. Each TP will be of 1 day and separated by a washout Period of 14-days. Post completion of the dose-escalation TPs, an additional dosing TP 4 will be included where the subjects from each TP (1 to 3), will receive control blisters induced on forearm (0.2 % cantharidin) at Day -10. The subjects in cohort 1 will receive GSK3358699 at a dose level already given in TP 1-3, and will then receive an intravenous in vivo LPS challenge at a dose not exceeding 0.75 nanogram per kilogram post administration of GSK3358699. The subjects will then have blisters induced on the forearm approximately 20 minutes after the challenge. LPS dose will be based on data of study 207654 (NCT03306589).
Drug: GSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

Biological: LPS
LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Experimental: GSK3358699, Part A, Cohort 2
Part A will comprise of 4 TPs. The subjects in this cohort will receive GSK3358699, as single escalation dose during TP (1 to 3) with planned escalated doses as 3 mg, 20 mg and 45 mg. Dose of 3 mg will be given as solution and that of 20 and 45 mg, as capsule. Each TP will be of 1 day and separated by a washout Period of 14-days. Post completion of the dose-escalation TPs, an additional dosing TP 4 will be included where the subjects from each TP (1 to 3), will receive control blisters induced on forearm (0.2 % cantharidin) at Day -10. The subjects in cohort 2 will receive GSK3358699 at a dose level already given in TP 1-3, and will then receive 60 microgram per meter^2 of in vivo GM CSF challenge as an intravenous infusion during TP 4, post administration of GSK3358699. The subjects will then have blisters induced on the forearm approximately 20 minutes after the challenge GM-CSF infusion. GM-CSF dose will be based on data of study 207654 (NCT03306589).
Drug: GSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

Biological: GM-CSF
The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Placebo Comparator: Placebo, Part A, Cohort 1
Part A will comprise of 4 TPs. The subjects in this cohort will receive matching Placebo solution to the study drug GSK3358699 solution for 1 mg and a matching placebo capsule to the study drug GSK3358699, 10 mg and 35 mg capsule, during TP (1 to 3). Each TP will be of 1 day and separated by a washout Period of 14-days. Post completion of the dose-escalation TPs, an additional dosing TP 4 will be included where the subjects from each TP (1 to 3), will receive control blisters induced on forearm (0.2 % cantharidin) at Day -10. The subjects in cohort 1 will receive Placebo at a dose level already given in TP 1-3, and will then receive an intravenous in vivo LPS challenge at a dose not exceeding 0.75 nanogram per kilogram post administration of Placebo. The subjects will then have blisters induced on the forearm approximately 20 minutes after the challenge. LPS dose will be based on data of study 207654 (NCT03306589).
Drug: Placebo
Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily

Biological: LPS
LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Placebo Comparator: Placebo, Part A, Cohort 2
Part A will comprise of 4 TPs. The subjects in this cohort will receive matching Placebo solution to the study drug GSK3358699 solution for 3 mg and a matching placebo capsule to the study drug GSK3358699, for 20 and 45 mg capsule, during TP (1 to 3). Each TP will be of 1 day and separated by a washout Period of 14-days. Post completion of the dose-escalation TPs, an additional dosing TP 4 will be included where the subjects from each TP (1 to 3), will receive control blisters induced on forearm (0.2 % cantharidin) at Day -10. The subjects in cohort 2 will receive Placebo at a dose level already given in TP 1-3, and will then receive 60 microgram per meter^2 of in vivo GM CSF challenge as an intravenous infusion during TP 4, post administration of Placebo. The subjects will then have blisters induced on the forearm approximately 20 minutes after the challenge GM-CSF infusion. GM-CSF dose will be based on data of study 207654 (NCT03306589).
Drug: Placebo
Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily

Biological: GM-CSF
The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Experimental: Part B, GSK3358699 under Fasted followed by Fed conditions
The subjects in this arm will receive single oral dose of GSK3358699, at a dose level evaluated in Part A, under fasted condition in TP1 followed by fed condition in TP2. This cohort intended to evaluate the effect of food.
Drug: GSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

Experimental: Part B, GSK3358699 under Fed followed by Fasted conditions
The subjects in this arm will receive single oral dose of GSK3358699, at a dose level evaluated in Part A, under fed condition in TP1 followed by fasted condition in TP2. This cohort intended to evaluate the effect of food.
Drug: GSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

Experimental: GSK3358699, Part C
The dose level for the first cohort in Part C will be decided following completion of Part A of the study for GSK3358699. The subjects in this arm will constitute 3 cohorts each (cohort 4 to 6), where the subjects will receive GSK3358699, as one repeat dose treatment once daily for 14-consecutive days. Subjects will have control blisters induced on the forearm (0.2% cantharidin) on Day -10. On the Day 14 of each cohort, each subject will receive an intravenous in vivo LPS challenge at a dose not exceeding 0.75 nanogram per kilogram or an intravenous infusion of GM-CSF, in vivo as 60 microgram per meter^2. The administration of LPS or GM CSF will be followed by blister induction on forearm (0.2 % cantharidin).
Drug: GSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

Biological: GM-CSF
The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C

Biological: LPS
LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Placebo Comparator: Placebo, Part C
The subjects in this cohort will receive a matching placebo to GSK3358699, Part C, as a single oral dose once daily for 14 consecutive days. The subjects in this arm will constitute 3 cohorts each (cohort 4 to 6), where the subjects will receive placebo, as one repeat dose treatment once daily for 14-consecutive days. Subjects will have control blisters induced on the forearm (0.2% cantharidin) on Day -10. On the Day 14 of each cohort, each subject will receive an intravenous in vivo LPS challenge at a dose not exceeding 0.75 nanogram per kilogram or an intravenous infusion of GM-CSF, in vivo as 60 microgram per meter^2. The administration of LPS or GM CSF will be followed by blister induction on forearm (0.2 % cantharidin).
Drug: Placebo
Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily

Biological: GM-CSF
The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C

Biological: LPS
LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.

Other: Cantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.




Primary Outcome Measures :
  1. Part A: Number of subjects with adverse events (AEs) and Serious adverse events (SAEs) [ Time Frame: Up to 17 weeks ]
    An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment.

  2. Part B: Number of subjects with AEs and SAEs [ Time Frame: Up to 4 weeks ]
    An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment.

  3. Part C: Number of subjects with AEs and SAEs [ Time Frame: Up to 7 weeks ]
    An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment.

  4. Part A: Number of subjects with abnormal clinical chemistry parameter's as measure of safety [ Time Frame: Up to 12 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal blood urea nitrogen (BUN), C-reactive protein (CRP), creatinine, glucose, sodium, potassium, calcium, Aspartate Aminotransferase, (AST)/ Serum Glutamic-Oxaloacetic Transaminase (SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP) levels, total and direct bilirubin, cholesterol, triglycerides, total protein, low density lipoprotein, high density lipoprotein and albumin.

  5. Part B: Number of subjects with abnormal clinical chemistry parameter's as measure of safety [ Time Frame: Up to 4 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal BUN, CRP, creatinine, glucose, sodium, potassium, calcium, AST/SGOT, ALT/SGPT, ALP levels, total and direct bilirubin, cholesterol, triglycerides, total protein, low density lipoprotein, high density lipoprotein and albumin.

  6. Part C: Number of subjects with abnormal clinical chemistry parameter's as measure of safety [ Time Frame: Up to 2 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal BUN, CRP, creatinine, glucose, sodium, potassium, calcium, AST/SGOT, ALT/SGPT, ALP levels, total and direct bilirubin, cholesterol (fasting), triglycerides, total protein, low density lipoprotein, high density lipoprotein and albumin.

  7. Part A: Number of subjects with abnormal hematology parameter's as measure of safety [ Time Frame: Up to 12 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal platelet counts, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, percent reticulocytes, RBC indices (mean corpuscle volume [MCV], mean corpuscle hemoglobin [MCH] and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and clotting parameter's like activated partial thromboplastin time (APTT), pro-thrombin (PT) times, and fibrinogen.

  8. Part B: Number of subjects with abnormal hematology parameter's as measure of safety [ Time Frame: Up to 4 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal platelet counts, RBC count, WBC count (absolute), hemoglobin, hematocrit, percent reticulocytes, RBC indices MCV, MCH and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and clotting parameter's APTT, PT times, and fibrinogen.

  9. Part C: Number of subjects with abnormal hematology parameter's as measure of safety [ Time Frame: Up to 2 weeks ]
    Blood samples will be collected and processed to measure the number of subjects with abnormal platelet counts, RBC count, WBC count (absolute), hemoglobin, hematocrit, percent reticulocytes, RBC indices MCV, MCH and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and clotting parameter's APTT, PT times, and fibrinogen.

  10. Part A: Number of subjects with abnormal urinalysis parameter's as measure of safety [ Time Frame: Up to 12 weeks ]
    Urine samples will be collected to evaluate specific gravity, pH, glucose, protein, blood, ketones by dipstick along with microscopic examination if blood or protein is abnormal.

  11. Part B: Number of subjects with abnormal urinalysis parameter's as measure of safety [ Time Frame: Up to 4 weeks ]
    Urine samples will be collected to evaluate specific gravity, pH, glucose, protein, blood, ketones by dipstick along with microscopic examination if blood or protein is abnormal.

  12. Part C: Number of subjects with abnormal urinalysis parameter's as measure of safety [ Time Frame: Up to 2 weeks ]
    Urine samples will be collected to evaluate specific gravity, pH, glucose, protein, blood, ketones by dipstick along with microscopic examination if blood or protein is abnormal.

  13. Part A: Number of subjects with abnormal 12 lead electrocardiograms (ECGs) findings [ Time Frame: Up to 12 weeks ]
    Triplicate 12-lead ECGs will be obtained prior to blood draws and dosing. Single ECGs will be taken at other time points.

  14. Part B: Number of subjects with abnormal 12 lead ECGs findings [ Time Frame: Up to 4 weeks ]
    Triplicate 12-lead ECGs will be obtained prior to blood draws and dosing. Single ECGs will be taken at other time points.

  15. Part C: Number of subjects with abnormal 12 lead ECG findings [ Time Frame: Up to 2 weeks ]
    Triplicate 12-lead ECGs will be obtained prior to blood draws and dosing. Single ECGs will be taken at other time points.

  16. Part A: Number of subjects with abnormal vital signs-systolic and diastolic blood pressure [ Time Frame: Up to 17 weeks ]
    The number of subjects with abnormal systolic and diastolic blood pressure values will be reported.

  17. Part B: Number of subjects with abnormal vital signs-systolic and diastolic blood pressure [ Time Frame: Up to 4 weeks ]
    The number of subjects with abnormal systolic and diastolic blood pressure values will be reported.

  18. Part C: Number of subjects with abnormal vital signs-systolic and diastolic blood pressure [ Time Frame: Up to 7 weeks ]
    The number of subjects with abnormal systolic and diastolic blood pressure values will be reported.

  19. Part A: Number of subjects with abnormal vital signs-temperature [ Time Frame: Up to 17 weeks ]
    The number of subjects with abnormal temperature values will be reported.

  20. Part B: Number of subjects with abnormal vital signs-temperature [ Time Frame: Up to 4 weeks ]
    The number of subjects with abnormal temperature values will be reported.

  21. Part C: Number of subjects with abnormal vital signs-temperature [ Time Frame: Up to 7 weeks ]
    The number of subjects with abnormal temperature values will be reported.

  22. Part A: Number of subjects with abnormal vital signs-heart rate [ Time Frame: Up to 17 weeks ]
    The number of subjects with abnormal heart rate values will be reported.

  23. Part B: Number of subjects with abnormal vital signs-heart rate [ Time Frame: Up to 4 weeks ]
    The number of subjects with abnormal heart rate values will be reported.

  24. Part C: Number of subjects with abnormal vital signs-heart rate [ Time Frame: Up to 7 weeks ]
    The number of subjects with abnormal heart rate values will be reported.

  25. Part A: Number of subjects with abnormal vital signs-respiratory rate [ Time Frame: Up to 17 weeks ]
    The number of subjects with abnormal respiratory rate values will be reported.

  26. Part B: Number of subjects with abnormal vital signs-respiratory rate [ Time Frame: Up to 4 weeks ]
    The number of subjects with abnormal respiratory rate values will be reported.

  27. Part C: Number of subjects with abnormal vital signs-respiratory rate [ Time Frame: Up to 7 weeks ]
    The number of subjects with abnormal respiratory rate values will be reported.


Secondary Outcome Measures :
  1. Part A: Plasma concentrations of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected for measurement of GSK3358699 concentrations in plasma.

  2. Part C: PLASMA concentrations of GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour. ]
    Blood samples will be collected for measurement of GSK3358699 concentrations in plasma.

  3. Part B: Plasma concentrations of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1,2,4,6,8,12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected for measurement of GSK3358699 concentrations in plasma.

  4. Part A: Area under the plasma concentration (AUC) from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) for Gsk3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  5. Part B: AUC (0-t) for GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1,2,4,6,8,12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  6. Part C: AUC (0-t) for GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  7. Part A: AUC pre dose to infinite (inf) time (AUC [0-inf]) of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  8. Part B: AUC (0-inf) time of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  9. Part C: AUC (0-inf) time of GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  10. Part A: Maximum plasma concentration (Cmax) of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  11. Part B: Cmax of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  12. Part C: Cmax of GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  13. Part A: Time to maximum plasma concentration (tmax) of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  14. Part B: tmax of GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  15. Part C: tmax of GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  16. Part A: Terminal elimination half-life (t1/2) of GSK3358699 in plasma [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  17. Part B: t1/2 of GSK3358699 in plasma [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  18. Part C: t1/2 of GSK3358699 in plasma [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  19. Part A: AUC pre-dose to 24 hours post-dose: AUC (0-24) for GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  20. Part B: AUC (0-24) for GSK3358699 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  21. Part C: AUC (0-24) for GSK3358699 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  22. Part A: AUC (0-t) for GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  23. Part B: AUC (0-t) for GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  24. Part C: AUC(0-t) for GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  25. Part A: AUC (0-inf) of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  26. Part B: AUC (0-inf) of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  27. Part C: AUC (0-inf) of GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  28. Part A: Cmax of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at 6 mL, per timepoint for measurement of GSK3206944 concentrations in plasma (approximately 1 mL per time-point up to and including 6 hours post dose and approximately 2 mL per time-point after 6 hours post-dose.

  29. Part B: Cmax of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  30. Part C: Cmax of GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  31. Part A: tmax of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected at specified time points for PK analysis.

  32. Part B: tmax of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected at specified time points for PK analysis.

  33. Part C: tmax of GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  34. Part A: t1/2 of GSK3206944 in plasma [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected at specified time points for PK analysis.

  35. Part B: t1/2 of GSK3206944 in plasma [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected at specified time points for PK analysis.

  36. Part C: t1/2 of GSK3206944 in plasma [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  37. Part A: AUC (0-24) for GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected at specified time points for PK analysis.

  38. Part B: AUC (0-24) for GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1 hour, 2,4, 6, 8, 12 hour; Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected at specified time points for PK analysis.

  39. Part C: AUC (0-24) for GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour ]
    Blood samples will be collected at specified time points for PK analysis.

  40. Part A: Plasma concentrations of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, and 30 minutes, 1 hour, 2 ,4, 6, 8, 12 hour), Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected for measurement of GSK3206944 concentrations in plasma.

  41. Part B: Plasma concentrations of GSK3206944 [ Time Frame: Day 1 (pre-dose, 15, 30 minutes; 1,2,4,6,8,12 hour; Day 2 (24 hour), Day 3 (48 hour) in each period ]
    Blood samples will be collected for measurement of GSK3206944 concentrations in plasma.

  42. Part C: Plasma concentrations of GSK3206944 [ Time Frame: Day 1: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 and 24 hour post-dose; Pre-dose samples on Days 4, 8 and 12; Day 14: pre-dose, 15 and 30 minutes, 1 hour, 2, 4, 6, 8, 12 hour); Day 15: 24 hour; Day 16: 48 hour. ]
    Blood samples will be collected for measurement of GSK3206944 concentrations in plasma.

  43. Part A: Monocyte intracellular concentration of GSK3206944 [ Time Frame: Day 1 (1 hour, 4 and 8 hour), Day 2 (24 hour), and Day 3 (48 hour) ]
    Blood samples will be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes.

  44. Part B: Monocyte intracellular concentration of GSK3206944 [ Time Frame: Day 1 (1 hour,4 hour, 8 hour), Day 2 (24 hour), Day 3 (48 hour) ]
    Blood samples will be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes.

  45. Part C: Monocyte intracellular concentration of GSK3206944 [ Time Frame: Day 1 (1, 4 and 8 hour), Pre dose on Days 4, 8 and 12, Day 14 (1, 4 and 8 hour), Day 15 (24 hour), Day 16 (48 hour) ]
    Blood samples will be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes.

  46. Part A: Plasma concentrations of monocyte chemoattractant protein (MCP)-1, in blood stimulated ex vivo with lipopolysaccharide (LPS) over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour, 4, 8, and 12 hour); Day 2 (24 hour), and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  47. Part A: Plasma concentrations of interleukin (IL)-6 in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour, 4, 8, and 12 hour); Day 2 (24 hour), and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  48. Part A: Plasma concentrations of monocyte chemoattractant protein tumor necrosis factor (TNF) in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour, 4, 8, and 12 hour); Day 2 (24 hour), and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  49. Part B: Plasma concentrations of MCP-1, in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour,4, 8, 12 hour), Day 2 (24 hour) and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  50. Part B: Plasma concentrations of IL-6 in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour,4, 8, 12 hour), Day 2 (24 hour) and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  51. Part B: Plasma concentrations of monocyte chemoattractant protein TNF in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1 (pre-dose, 1 hour,4, 8, 12 hour), Day 2 (24 hour) and Day 3 (48 hour) ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  52. Part C: Plasma concentrations of MCP-1, in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1: pre-dose and 1, 4 and 8 hours post-dose; pre-dose on Days 2,4,8 and 12; Day 14: pre-dose and 1, 4 and 8 hours post-dose; Day 15: 24 hour ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  53. Part C: Plasma concentrations of IL-6 in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1: pre-dose and 1, 4 and 8 hours post-dose; pre-dose on Days 2,4,8 and 12; Day 14: pre-dose and 1, 4 and 8 hours post-dose; Day 15: 24 hour ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.

  54. Part C: Plasma concentrations of monocyte chemoattractant protein TNF in blood stimulated ex vivo with LPS over time [ Time Frame: Day -1, Day 1: pre-dose and 1, 4 and 8 hours post-dose; pre-dose on Days 2,4,8 and 12; Day 14: pre-dose and 1, 4 and 8 hours post-dose; Day 15: 24 hour ]
    Whole blood samples of 1 mL will be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediator will be analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
Inclusion Criteria: - Subjects enrolled into the study, where they will be administered LPS or GM-CSF challenge, must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Subjects enrolled into the study where they will not be administered LPS or GM-CSF challenge must be 18 to 65 years of age inclusive, at the time of signing the informed consent. - Subjects must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight must be > = 50 kilogram (kg) and body mass index (BMI) within the range 18.5-35.0 kg per square meter (kg/m^2) (inclusive). - Male subjects agreeing to use contraceptive methods during the treatment Period and for at least 91 days, after the last dose of study treatment and refrain from donating sperm during this Period. - Capable of giving informed consent. Exclusion Criteria: - Current or chronic history of pancreatitis, diabetes mellitus or impaired glucose tolerance, gastrointestinal disease, liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), anaphylaxis, and /or anaphylactoid (resembling anaphylaxis) reactions [Sampson et al 2006], cardiac disease including clinically significant ventricular arrhythmias or long QT syndrome, renal disease where clinically significant (minor abnormalities may be permitted base on discussion between investigator and medical monitor), respiratory disease or conditions including but not limited to asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis and any current respiratory infection (childhood asthma is not an exclusion criterion), sensitivity or severe allergic responses to any of the challenge agents or cantharidin, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation; frequent vasovagal syncope, surgery requiring general anaesthetic or significant trauma in 3 months leading to study enrolment, relevant skin conditions (e.g. recent history of eczema or recurrent eczema, keloid, skin allergies, psoriasis, atopic dermatitis, and vitiligo) which in the opinion of the investigator could pose safety issues or cause interference with study procedures, sepsis, coagulation disorders, peripheral edema, lymphangitis, lymphedema, pleural or pericardial effusion, hemorrhage (eg sub-arachnoid) or hemophilia or a related bleeding disorder. - History of malignancies e.g. recurrent basal cell carcinoma, hematological malignancy. - For subjects receiving cantharidin: Presence on either forearm of tattoos, naevi, hypertrophic scars, keloids, hyper- or hypo- pigmentation that may, in the opinion of the Investigator, interfere with study assessments. Subjects with very fair skin, very dark skin, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments. - Family history of premature cardiovascular disease or long QT syndrome. - QT interval with Fridericia's correction (QTcF) > 450 millisecond (msec), based on averaged QTcF values of triplicate ECGs obtained over a brief recording period. - Unable or unwilling to refrain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study treatment until completion of the follow-up visit. Paracetamol, at a dose of <= 2 grams per day was permitted for use anytime during the study. Other concomitant medications will be considered on case by case basis. - The subjects have participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in the study: 30 days; 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or currently in a study of an investigational device. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Previous exposure to intravenous lipopolysaccharide (LPS) in a clinical research setting. - Alanine transaminase (ALT) >1.5x upper limit of normal (ULN) at screening. - Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - A positive pre-study drug/alcohol screen at screening. - A positive test for human immunodeficiency virus (HIV) antibody at screening. - Persistent clinically significant abnormal C-reactive protein (CRP) levels at screening - Persistent clinically significant abnormal white cell count (WCC) levels at screening (if clinically significant abnormality is detected, WCC can be retested as clinically indicated) - Platelets < 150 x 10^9 per liter (L) at screening. - Fasted Triglycerides >3.4 millimole per liter (mmol/L) at screening. - Fasted Total cholesterol >7.7 mmol/L at screening. - Random glucose > = 11.1 mmol/L at screening. - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL). - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Unable to comply with precautions to minimize phototoxicity risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426995


Locations
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United Kingdom
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03426995    
Other Study ID Numbers: 207546
2017-003997-15 ( EudraCT Number )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Sargramostim
Cantharidin
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action