Trial · NCT02603172
A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis
NCT02603172, Phase 1, Terminated, GlaxoSmithKline; results first posted 2019-09-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis. Trials, record NCT02603172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02603172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis
- NCT number
- NCT02603172
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Amyloidosis
- Interventions
- GSK3039294
- First posted
- 2015-11-11
- Last updated
- 2019-09-23
- Other registries' IDs
- eudract:2015-003088-13
- Results first posted
- 2019-09-23
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. Safety population consist of all participants who received at least one dose of the study medication. |
| Primary | Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | 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). |
| Primary | Part A: Number of Participants With Emergent Hematology by PCI Criteria | 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). |
| Primary | Part A: Number of Participants With Abnormal Urinalysis Data by Dipstick | 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. |
| Primary | Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) | 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. |
| Primary | Part A: Mean Change From Baseline in Heart Rate by 12-lead ECG | 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. |
| Primary | Part A: Mean Change From Baseline in Blood Pressure (BP) | 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. |
| Primary | Part A: Mean Change From Baseline in Pulse Rate | 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. |
| Primary | Part A: Mean Change From Baseline in Temperature | 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. |
| Primary | Part B:Number of Participants With AEs and SAEs | 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 result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 14 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Day 1 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Emergent Hematology by PCI Criteria | Day 1 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Abnormal Urinalysis Data by Dipstick | Day 1 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Safety Population | Millisecond | MEAN |
| PRIMARY | Part A: Mean Change From Baseline in Heart Rate by 12-lead ECG | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Safety population. | Beats per minute | MEAN |
| PRIMARY | Part A: Mean Change From Baseline in Blood Pressure (BP) | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Safety population. | Millimeter of mercury | MEAN |
| PRIMARY | Part A: Mean Change From Baseline in Pulse Rate | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Safety population. | Beats per minute | MEAN |
| PRIMARY | Part A: Mean Change From Baseline in Temperature | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Safety population. | Celsius | MEAN |
| PRIMARY | Part B:Number of Participants With AEs and SAEs | Cohort 3: Up to Day 21; Cohort 4: Up to Day 35 | Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group556
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 200 mg | Any AEs | 1 | Participants | |
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 600 mg | Any AEs | 6 | Participants | |
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 1200 mg | Any AEs | 5 | Participants | |
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 200 mg | Any SAEs | 0 | Participants | |
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 600 mg | Any SAEs | 0 | Participants | |
| Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: GSK3039294 1200 mg | Any SAEs | 0 | Participants | |
| Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Part A: GSK3039294 200 mg | Albumin: low | 0 | Participants | |
| Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Part A: GSK3039294 600 mg | Albumin: low | 0 | Participants | |
| Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Part A: GSK3039294 1200 mg | Albumin: low | 0 | Participants | |
| Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Part A: GSK3039294 200 mg | Albumin: high | 0 | Participants |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 200 mg + GSK3039294 600 mg | 7 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD | 1 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 600 mg +GSK3039294 1200 mg | 8 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 600 mg +GSK3039294 1200 mg/GSK3039294 600 mg QD | 1 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 600 mg QD | 0 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 (Cohort 4a) | 0 | |
| Part A (Approximately 16 Weeks) | STARTED | GSK3039294 (Cohort 4b) | 0 | |
| Part A (Approximately 16 Weeks) | STARTED | Part C: GSK3039294 | 0 | |
| Part A (Approximately 16 Weeks) | COMPLETED | GSK3039294 200 mg + GSK3039294 600 mg | 7 | |
| Part A (Approximately 16 Weeks) | COMPLETED | GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD | 1 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events133
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial tachycardia | Cardiac disorders | Part A: GSK3039294 200 mg | 0 | 8 | 0 |
| other | Atrial tachycardia | Cardiac disorders | Part A: GSK3039294 600 mg | 1 | 16 | 1 |
| other | Atrial tachycardia | Cardiac disorders | Part A: GSK3039294 1200 mg | 1 | 8 | 1 |
| other | Atrial tachycardia | Cardiac disorders | Part B: Cohort 3- GSK3039294 600 mg QD | 0 | 8 | 0 |
| other | Atrial tachycardia | Cardiac disorders | Part B: Cohort 4a- GSK3039294 | 0 | 0 | 0 |
| other | Atrial tachycardia | Cardiac disorders | Part B: Cohort 4b- GSK3039294 | 0 | 0 | 0 |
| other | Atrial tachycardia | Cardiac disorders | Part C: GSK3039294 | 0 | 0 | 0 |
| other | Accelerated idioventricular rhythm | Cardiac disorders | Part A: GSK3039294 200 mg | 0 | 8 | 0 |
| other | Accelerated idioventricular rhythm | Cardiac disorders | Part A: GSK3039294 600 mg | 1 | 16 | 1 |
| other | Accelerated idioventricular rhythm | Cardiac disorders | Part A: GSK3039294 1200 mg | 0 | 8 | 0 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: GSK3039294 200 mg | 0 | 8 |
| Total, all-cause mortality | Part A: GSK3039294 600 mg | 0 | 16 |
| Total, all-cause mortality | Part A: GSK3039294 1200 mg | 0 | 8 |
| Total, all-cause mortality | Part B: Cohort 3- GSK3039294 600 mg QD | 0 | 8 |
| Total, all-cause mortality | Part B: Cohort 4a- GSK3039294 | 0 | 0 |
| Total, all-cause mortality | Part B: Cohort 4b- GSK3039294 | 0 | 0 |
| Total, all-cause mortality | Part C: GSK3039294 | 0 | 0 |
| Total, other adverse events | Part A: GSK3039294 200 mg | 1 | 8 |
| Total, other adverse events | Part A: GSK3039294 600 mg | 6 | 16 |
| Total, other adverse events | Part A: GSK3039294 1200 mg | 5 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02603172
GET https://conductscience.org/api/trials/v1/NCT02603172/registered?page=2