NCT02603172 is a Phase 1 clinical trial of GSK3039294 in Amyloidosis, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02603172?

NCT02603172 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02603172?

Interventions in NCT02603172: GSK3039294.

What condition does NCT02603172 study?

NCT02603172 studies Amyloidosis.

Is NCT02603172 still recruiting?

NCT02603172 is currently terminated. Last updated 23 September 2019.

Are results published for NCT02603172?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-23 · How we verify

NCT02603172

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis

Terminated Phase 1 Results posted Last updated 23 September 2019

What this trial tests

Phase 1 trial testing GSK3039294 in Amyloidosis in 23 participants. Terminated before completion.

Timeline

12 May 2016

Primary endpoint
10 May 2017

10 May 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	12 May 2016
Primary completion	10 May 2017
Estimated completion	10 May 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

GSK3039294 — full drug profile →

Conditions studied

Amyloidosis — all drugs for Amyloidosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Amyloidosis. 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.

Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · Up to Day 14

An AE is any untoward medical occurrence in a participants or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization clinical chemor prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-thr

Any AEs

Group	Value	95% CI
Part A: GSK3039294 200 mg	1
Part A: GSK3039294 600 mg	6
Part A: GSK3039294 1200 mg	5

Any SAEs

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria Primary · Day 1

PCI ranges for the clinical chemistry parameters were as follows : albumin (low: \<0.86 gram \[g\] per liter \[L\]), calcium (low: \<0.91 millimole \[mmol\]/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total carbon dioxide (CO2) (low: \<0.86 mmol/L and high: \>1.14 mmol/L).

Albumin: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Albumin: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Calcium: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Calcium: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Glucose: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Glucose: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Potassium: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Potassium: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Part A: Number of Participants With Emergent Hematology by PCI Criteria Primary · Day 1

PCI ranges for the hematology parameters were as follows: white blood cell (WBC) count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of red blood cell \[RBC\] in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L).

Hematocrit: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Hematocrit: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Hemoglobin: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Hemoglobin: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Leukocytes: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Leukocytes: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Lymphocytes: low

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Lymphocytes: high

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Part A: Number of Participants With Abnormal Urinalysis Data by Dipstick Primary · Day 1

Urine samples were collected and urinalysis included analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.

Group	Value	95% CI
Part A: GSK3039294 200 mg	0
Part A: GSK3039294 600 mg	0
Part A: GSK3039294 1200 mg	0

Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Primary · Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

Triplicate ECG was measured in semi-supine position after 5 minutes (min) rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

PR interval: 15 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	0.5	± 5.47
Part A: GSK3039294 600 mg	0.9	± 7.05
Part A: GSK3039294 1200 mg	-0.3	± 3.47

PR interval: 30 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.3	± 6.24
Part A: GSK3039294 600 mg	3.1	± 5.65
Part A: GSK3039294 1200 mg	0.2	± 5.35

PR interval: 1 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.3	± 8.72
Part A: GSK3039294 600 mg	3.2	± 6.06
Part A: GSK3039294 1200 mg	0.3	± 7.19

PR interval: 2 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.3	± 4.82
Part A: GSK3039294 600 mg	0.2	± 5.50
Part A: GSK3039294 1200 mg	0.3	± 5.42

PR interval: 4 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-8.3	± 6.41
Part A: GSK3039294 600 mg	-7.3	± 8.22
Part A: GSK3039294 1200 mg	-7.1	± 4.66

PR interval: 6 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-6.8	± 7.04
Part A: GSK3039294 600 mg	-7.6	± 9.60
Part A: GSK3039294 1200 mg	-4.0	± 6.98

PR interval: 8 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-5.0	± 6.48
Part A: GSK3039294 600 mg	-6.1	± 8.38
Part A: GSK3039294 1200 mg	-5.0	± 5.27

PR interval: 12 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-3.8	± 7.42
Part A: GSK3039294 600 mg	-6.1	± 7.77
Part A: GSK3039294 1200 mg	-4.7	± 9.69

Part A: Mean Change From Baseline in Heart Rate by 12-lead ECG Primary · Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

Triplicate ECG was measured in semi-supine position after 5 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures the heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

15 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.1	± 2.90
Part A: GSK3039294 600 mg	0.9	± 4.27
Part A: GSK3039294 1200 mg	0.6	± 1.96

30 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.0	± 3.10
Part A: GSK3039294 600 mg	0.9	± 4.64
Part A: GSK3039294 1200 mg	1.0	± 2.62

1 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.0	± 4.95
Part A: GSK3039294 600 mg	-0.4	± 3.72
Part A: GSK3039294 1200 mg	1.8	± 1.77

2 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-1.1	± 3.97
Part A: GSK3039294 600 mg	-0.7	± 3.38
Part A: GSK3039294 1200 mg	1.0	± 2.27

4 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	8.1	± 4.13
Part A: GSK3039294 600 mg	9.7	± 4.29
Part A: GSK3039294 1200 mg	8.3	± 5.27

6 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	5.8	± 4.21
Part A: GSK3039294 600 mg	5.7	± 4.63
Part A: GSK3039294 1200 mg	7.3	± 3.52

8 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	2.4	± 6.67
Part A: GSK3039294 600 mg	4.1	± 4.79
Part A: GSK3039294 1200 mg	5.2	± 5.55

12 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	1.1	± 2.17
Part A: GSK3039294 600 mg	3.8	± 4.15
Part A: GSK3039294 1200 mg	6.3	± 2.69

Part A: Mean Change From Baseline in Blood Pressure (BP) Primary · Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

Systolic BP and diastolic BP were measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

Diastolic BP: 15 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.6	± 3.11
Part A: GSK3039294 600 mg	-0.4	± 3.86
Part A: GSK3039294 1200 mg	3.5	± 4.86

Diastolic BP: 30 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.1	± 1.54
Part A: GSK3039294 600 mg	0.1	± 3.72
Part A: GSK3039294 1200 mg	2.9	± 4.04

Diastolic BP: 1 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.0	± 4.13
Part A: GSK3039294 600 mg	-1.1	± 3.53
Part A: GSK3039294 1200 mg	0.9	± 4.25

Diastolic BP: 2 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-3.1	± 3.16
Part A: GSK3039294 600 mg	-1.7	± 4.95
Part A: GSK3039294 1200 mg	1.4	± 4.06

Diastolic BP: 4 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-7.3	± 2.45
Part A: GSK3039294 600 mg	-6.5	± 5.83
Part A: GSK3039294 1200 mg	-2.5	± 6.54

Diastolic BP: 6 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-4.7	± 3.82
Part A: GSK3039294 600 mg	-4.8	± 4.80
Part A: GSK3039294 1200 mg	-0.3	± 4.38

Diastolic BP: 8 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-2.0	± 5.47
Part A: GSK3039294 600 mg	-1.9	± 6.16
Part A: GSK3039294 1200 mg	0.8	± 6.09

Diastolic BP: 12 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-7.1	± 2.88
Part A: GSK3039294 600 mg	-4.6	± 5.77
Part A: GSK3039294 1200 mg	-2.6	± 7.39

Part A: Mean Change From Baseline in Pulse Rate Primary · Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

15 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	0.2	± 2.15
Part A: GSK3039294 600 mg	-0.4	± 2.25
Part A: GSK3039294 1200 mg	0.4	± 3.14

30 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.4	± 3.06
Part A: GSK3039294 600 mg	0.5	± 2.17
Part A: GSK3039294 1200 mg	1.7	± 2.91

1 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.2	± 5.17
Part A: GSK3039294 600 mg	0.4	± 3.10
Part A: GSK3039294 1200 mg	1.3	± 3.51

2 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.7	± 1.76
Part A: GSK3039294 600 mg	-0.3	± 5.00
Part A: GSK3039294 1200 mg	1.5	± 2.36

4 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	9.3	± 4.64
Part A: GSK3039294 600 mg	9.0	± 4.90
Part A: GSK3039294 1200 mg	7.9	± 4.01

6 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	7.1	± 6.71
Part A: GSK3039294 600 mg	4.6	± 4.44
Part A: GSK3039294 1200 mg	7.5	± 3.59

8 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	4.4	± 6.29
Part A: GSK3039294 600 mg	4.4	± 5.72
Part A: GSK3039294 1200 mg	5.0	± 5.61

12 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	2.3	± 3.58
Part A: GSK3039294 600 mg	3.8	± 3.82
Part A: GSK3039294 1200 mg	5.5	± 4.01

Part A: Mean Change From Baseline in Temperature Primary · Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

Temperature was measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

15 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.18	± 0.292
Part A: GSK3039294 600 mg	-0.00	± 0.339
Part A: GSK3039294 1200 mg	0.10	± 0.239

30 minutes

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.14	± 0.374
Part A: GSK3039294 600 mg	-0.02	± 0.369
Part A: GSK3039294 1200 mg	0.09	± 0.253

1 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.26	± 0.469
Part A: GSK3039294 600 mg	0.09	± 0.380
Part A: GSK3039294 1200 mg	0.17	± 0.255

2 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.06	± 0.288
Part A: GSK3039294 600 mg	0.09	± 0.278
Part A: GSK3039294 1200 mg	0.21	± 0.230

4 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	0.24	± 0.329
Part A: GSK3039294 600 mg	0.27	± 0.453
Part A: GSK3039294 1200 mg	0.34	± 0.350

6 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	0.24	± 0.250
Part A: GSK3039294 600 mg	0.53	± 0.318
Part A: GSK3039294 1200 mg	0.45	± 0.334

8 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	-0.00	± 0.438
Part A: GSK3039294 600 mg	0.37	± 0.427
Part A: GSK3039294 1200 mg	0.47	± 0.381

12 hour

Group	Value	95% CI
Part A: GSK3039294 200 mg	0.10	± 0.463
Part A: GSK3039294 600 mg	0.19	± 0.486
Part A: GSK3039294 1200 mg	0.36	± 0.534

Part B:Number of Participants With AEs and SAEs Primary · Cohort 3: Up to Day 21; Cohort 4: Up to Day 35

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A 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 and other important medical events judged by the investigator that may not be immediately life-threatening or re

Any AE

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	7

Any SAE

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	1

Part B: Number of Participants With Emergent Clinical Chemistry by PCI Criteria Primary · Cohort 3 and 4: Up to Day 3

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<0.86 g/L), calcium (low: \<0.91 mmol/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total CO2 (low: \<0.86 mmol/L and high: \>1.14 mmol/L).

Albumin: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Albumin: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Calcium: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Calcium: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Glucose: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Glucose: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Potassium: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Potassium: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Part B: Number of Participants With Emergent Hematology by PCI Criteria Primary · Cohort 3 and 4: Up to Day 3

PCI ranges for the hematology parameters were as follows: WBC count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of RBC in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L).

Hematocrit: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Hematocrit: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Hemoglobin: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Hemoglobin: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Leukocytes: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Leukocytes: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Lymphocytes: low

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Lymphocytes: high

Group	Value	95% CI
Part B: Cohort 3- GSK3039294 600 mg QD	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Part A: Up to Day 14; Part B (Cohort 3: Up to Day 21, Cohort 4a and 4b: Up to Day 35); and Part C: Up to Day 63. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: GSK3039294 200 mg

Serious: 0/8 (0%)

Deaths: 0/8

Part A: GSK3039294 600 mg

Serious: 0/16 (0%)

Deaths: 0/16

Part A: GSK3039294 1200 mg

Serious: 0/8 (0%)

Deaths: 0/8

Part B: Cohort 3- GSK3039294 600 mg QD

Serious: 1/8 (13%)

Deaths: 0/8

Part B: Cohort 4a- GSK3039294

Serious: 0

Deaths: 0

Part B: Cohort 4b- GSK3039294

Serious: 0

Deaths: 0

Part C: GSK3039294

Serious: 0

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Part A: GSK3039294 200 mg	Part A: GSK3039294 600 mg	Part A: GSK3039294 1200 mg	Part B: Cohort 3- GSK30392…	Part B: Cohort 4a- GSK3039…	Part B: Cohort 4b- GSK3039…	Part C: GSK3039294
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Part A: GSK3039294 200 mg	Part A: GSK3039294 600 mg	Part A: GSK3039294 1200 mg	Part B: Cohort 3- GSK30392…	Part B: Cohort 4a- GSK3039…	Part B: Cohort 4b- GSK3039…	Part C: GSK3039294
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Atrial tachycardia	Cardiac disorders	—	—	—	—	—	—	—
Accelerated idioventricular rhythm	Cardiac disorders	—	—	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—	—	—	—
Catheter site haematoma	General disorders	—	—	—	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Abnormal dreams	Psychiatric disorders	—	—	—	—	—	—	—
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Supraventricular tachycardia.

Data from ClinicalTrials.gov NCT02603172 adverse events section.

Sponsor's own description

GSK3039294 has been developed in order to offer an orally available alternative to parenteral CPHPC (GSK2315698 \[metabolite of GSK3039294\]) for plasma serum amyloid P component (SAP) depletion prior to use of anti SAP monoclonal antibody (mAb) in the treatment of systemic amyloidosis. This phase 1 study is intended to study safety, tolerability and pharmacokinetic (PK) profile of GSK3039294 in humans. This study consists of three parts. Part A will evaluate safety and tolerability of single doses of GSK3039294 in healthy subjects, Part B will evaluate safety and tolerability of repeat doses of GSK3039294 in healthy subjects, and Part C will evaluate safety and tolerability of repeat doses of GSK3039294 in subjects with systemic amyloidosis. Part A is a single dose, open label, dose escalation study. Two cohorts of subjects will be enrolled to provide data from 6 subjects per cohort and up to 4 different doses (2 dose levels per cohort) of GSK3039294 will be tested. For Cohorts 1 and 2, each subject may take part in two dosing periods. Part B is repeat dose, open label, dose escalation study. Sufficient number of subjects will be enrolled in Cohort 3a to ensure 6 completers (Cohort 3b will be conducted if required) and GSK3039294 will be administered repeatedly for a total of 21 days. Each subject will take part in a single study period. In Part C a single dose level of GSK3039294 will be tested for 21 days repeat dose, in 12 subjects with systemic amyloidosis. Each subject will take part in a single study period. The total duration for Part A is approximately 8 weeks, Part B is approximately 8-9 weeks, and Part C is approximately 13 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pan-Amyloid Reactive Peptides p5+14 and p5R Exhibit Specific Charge-Dependent Binding to Glycosaminoglycans.
Hancock TJ, Williams AD, Foster JS, Wall JS, et al · · 2025 · PMID 41011213 · DOI 10.3390/ph18091340

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02603172 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 23 September 2019

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/NCT02603172.

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NCT02603172

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK3039294

Other recruiting trials for Amyloidosis

Other GlaxoSmithKline trials

Verify against primary sources