Adults 18 to 60, any sex, with Pancreatitis, Acute Necrotizing. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part APrimary· Up to Day 22
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the
Any AE
Group
Value
95% CI
Part A: Placebo
3
Part A-Cohort 1: GSK3335065 0.1 mg
4
Part A-Cohort 2: GSK3335065 0.25 mg
3
Part A-Cohort 3: GSK3335065 1.3 mg
1
Any SAE
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
1
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part APrimary· Up to Day 22
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8x10\^9 cells per liter \[cells/L\]); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). Data for worst-case post-Baseline is presented. Baseline was defined as the latest pre-dose assessmen
Hemoglobin; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
Hemoglobin; High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Hematocrit; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
Hematocrit; High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Lymphocytes; Low
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Lymphocytes; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
Neutrophils; Low
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Neutrophils; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part APrimary· Up to Day 22
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 millimoles per liter \[mmol/L\]); alanine aminotransferase (ALT) (high: \>=2xupper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2xULN); alkaline phosphatase (ALP) (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). D
Albumin; Low
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Albumin; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
ALP; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
ALP; High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
ALT; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
ALT; High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
AST; Normal
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
AST; High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Number of Participants With Abnormal Urine Parameters-Part APrimary· Up to Day 22
Urine samples were taken for the assessment of following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed and collected for any abnormal dipstick results. Number of participants with abnormal urine parameters any time post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
1
Part A-Cohort 3: GSK3335065 1.3 mg
1
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part APrimary· Up to Day 22
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF) and Bazett's QT interval corrected for heart rate (QTcB). ECG measurements were preceded by at least 5 minutes rest for the participant in a semi-recumbent position. Number of participants with abnormal-clinically significant and abnormal-not clinically significant ECG findings at worst case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing st
Abnormal-clinically significant
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Abnormal-not clinically significant
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
3
Part A-Cohort 3: GSK3335065 1.3 mg
0
Number of Participants With Abnormal Vital Signs-Part APrimary· Up to Day 22
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, respiration rate and temperature were measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Participants are counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change"
DBP; To Low
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
DBP; To Normal or no change
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
DBP; To High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
SBP; To Low
Group
Value
95% CI
Part A: Placebo
1
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
SBP; To Normal or no change
Group
Value
95% CI
Part A: Placebo
4
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
SBP; To High
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Heart rate; To Low
Group
Value
95% CI
Part A: Placebo
0
Part A-Cohort 1: GSK3335065 0.1 mg
0
Part A-Cohort 2: GSK3335065 0.25 mg
0
Part A-Cohort 3: GSK3335065 1.3 mg
0
Heart rate; To Normal or no change
Group
Value
95% CI
Part A: Placebo
5
Part A-Cohort 1: GSK3335065 0.1 mg
6
Part A-Cohort 2: GSK3335065 0.25 mg
6
Part A-Cohort 3: GSK3335065 1.3 mg
1
Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-t]) for GSK3335065-Part A (Cohorts 1 and 2)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose
Blood samples for pharmacokinetic (PK) analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. PK Parameter Population comprised of all active participants whose PK sample was obtained and analyzed and who provided PK parameters.
Group
Value
95% CI
Part A-Cohort 1: GSK3335065 0.1 mg
14.1222
± 576.3
Part A-Cohort 2: GSK3335065 0.25 mg
201.1366
± 30.9
AUC(0-t) for GSK3335065-Part A (Cohorts 3 to 8)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Group
Value
95% CI
Part A-Cohort 3: GSK3335065 1.3 mg
2701.9080
± NA
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-Inf]) for GSK3335065-Part A (Cohorts 1 and 2)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.
Group
Value
95% CI
Part A-Cohort 1: GSK3335065 0.1 mg
51.68
± NA
Part A-Cohort 2: GSK3335065 0.25 mg
310.46
± 26.2
AUC(0-Inf) for GSK3335065-Part A (Cohorts 3 to 8)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Group
Value
95% CI
Part A-Cohort 3: GSK3335065 1.3 mg
2811.51
± NA
Time of the Last Measurable Concentration (Tlast) of GSK3335065-Part A (Cohorts 1 and 2)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose
Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Group
Value
95% CI
Part A-Cohort 1: GSK3335065 0.1 mg
9.0006
0.333 – 71.700
Part A-Cohort 2: GSK3335065 0.25 mg
72.0250
72.000 – 72.100
Tlast of GSK3335065-Part A (Cohorts 3 to 8)Secondary· 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Group
Value
95% CI
Part A-Cohort 3: GSK3335065 1.3 mg
168.0000
168.000 – 168.000
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part A: Placebo
Serious: 0/5 (0%)
Deaths: 0/5
Part A-Cohort 1: GSK3335065 0.1 mg
Serious: 0/6 (0%)
Deaths: 0/6
Part A-Cohort 2: GSK3335065 0.25 mg
Serious: 0/6 (0%)
Deaths: 0/6
Part A-Cohort 3: GSK3335065 1.3 mg
Serious: 1/1 (100%)
Deaths: 0/1
Part A-Cohort 4: GSK335065 2.6 mg
Serious: 0
Deaths: 0
Part A-Cohort 5: GSK335065 5.5 mg
Serious: 0
Deaths: 0
Part A-Cohort 6: GSK335065 12 mg
Serious: 0
Deaths: 0
Part A-Cohort 7: GSK335065 35 mg
Serious: 0
Deaths: 0
Part A-Cohort 8: GSK335065 54 mg
Serious: 0
Deaths: 0
Part B: Placebo
Serious: 0
Deaths: 0
Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion
Serious: 0
Deaths: 0
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Serious: 0
Deaths: 0
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Serious: 0
Deaths: 0
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them at this level throughout the treatment period. This study will utilize an adaptive design and is divided into 3 parts. Part A will consist of 8 cohorts (1-8) and is Single Ascending Dose (SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of dosing in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV constant infusion for 7 days in males and will consist of four cohorts (9-12). Part C consists of a single dose of GSK3335065 by IV bolus (cohort 13), and a single dose followed by continuous infusion over 7 days (cohort 14) in females of non-child bearing potential (WONCBP). Total 64 subjects will be evaluated in the study of which Part A will include 16 healthy male subjects, Part B will include 32 healthy male subjects and Part C will include 16 WONCBP. In Part A, cohorts 1 and 2 will last up to 19 weeks and cohorts 3 to 8 will last up to 7 weeks and Part B will last up to 13 weeks. In Part C cohort 7 will last up to 7 weeks and cohort 8 will last for 13 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Other recruiting trials for Pancreatitis, Acute Necrotizing
Currently open trials in the same condition.
NCT07406698 — Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis
· NA
· recruiting
NCT05451901 — Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
· NA
· recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 16 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03245619.