Trial Outcomes & Findings for Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT05677347)
NCT ID: NCT05677347
Last Updated: 2024-10-15
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
COMPLETED
PHASE1
12 participants
Up to 18 days
2024-10-15
Participant Flow
All the 12 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD
Eligible participants received a single dose (SD) of GSK3923868 500 microgram (mcg) in Treatment Period 1 followed by a single dose of placebo matching GSK3923868 in Treatment Period 2. Participants also received a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD
Eligible participants received a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
Eligible participants received a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
Eligible participants received a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
|---|---|---|---|---|
|
Treatment Period 1 (3 Days)
STARTED
|
3
|
3
|
3
|
3
|
|
Treatment Period 1 (3 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
|
Treatment Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (up to 6 Days)
STARTED
|
3
|
3
|
3
|
3
|
|
Washout Period 1 (up to 6 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
|
Washout Period 1 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (3 Days)
STARTED
|
3
|
3
|
3
|
3
|
|
Treatment Period 2 (3 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
|
Treatment Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (up to 6 Days)
STARTED
|
3
|
3
|
3
|
3
|
|
Washout Period 2 (up to 6 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
|
Washout Period 2 (up to 6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (up to 15 Days)
STARTED
|
3
|
3
|
3
|
3
|
|
Treatment Period 3 (up to 15 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
|
Treatment Period 3 (up to 15 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD
n=3 Participants
Eligible participants received a single dose (SD) of GSK3923868 500 microgram (mcg) in Treatment Period 1 followed by a single dose of placebo matching GSK3923868 in Treatment Period 2. Participants also received a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD
n=3 Participants
Eligible participants received a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
n=3 Participants
Eligible participants received a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD
n=3 Participants
Eligible participants received a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by GSK3923868 1000 mcg in Treatment Period 2. Participants also received a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There was a washout period between each treatment period. Participants had a follow-up of 14 days after the last dose of GSK3923868.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.7 YEARS
STANDARD_DEVIATION 2.31 • n=5 Participants
|
59.3 YEARS
STANDARD_DEVIATION 5.69 • n=7 Participants
|
63.3 YEARS
STANDARD_DEVIATION 7.23 • n=5 Participants
|
68.0 YEARS
STANDARD_DEVIATION 1.00 • n=4 Participants
|
64.6 YEARS
STANDARD_DEVIATION 5.50 • n=21 Participants
|
|
Sex/Gender, Customized
De-identified
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 18 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868
Non-SAE
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Outcome measures
| Measure |
Placebo SD
n=3 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868
Non-SAE
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868
SAE
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 18 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868
Clinical Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=3 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868
Hematology
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868
Clinical Chemistry
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine by dipstick. Number of participants with clinically significant changes in urinalysis parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=3 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 18 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868
12-Lead ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=3 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868
Vital Signs
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868
12-Lead ECG
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 18 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment.
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo SD
n=3 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2Population: This analysis was performed on Pharmacokinetic (PK) Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose
|
23463.81 Hours* picograms per milliliter
Geometric Coefficient of Variation 24.02
|
46553.52 Hours* picograms per milliliter
Geometric Coefficient of Variation 21.29
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2Population: This analysis was performed on PK Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for PK analysis of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK3923868 for Single Dose
|
23443.19 Hours* picograms per milliliter
Geometric Coefficient of Variation 23.96
|
46519.91 Hours* picograms per milliliter
Geometric Coefficient of Variation 21.28
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3Population: This analysis was performed on PK Population which included all randomized participants in Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points.
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose
Day 1
|
42593.74 Hours* picograms per milliliter
Geometric Coefficient of Variation 19.93
|
—
|
—
|
|
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose
Day 14
|
40787.96 Hours* picograms per milliliter
Geometric Coefficient of Variation 12.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2Population: This analysis was performed on PK Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose
|
4823.19 Picograms per milliliter
Geometric Coefficient of Variation 26.72
|
10042.80 Picograms per milliliter
Geometric Coefficient of Variation 11.93
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2Population: This analysis was performed on PK Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 Participants
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose
|
1.00 Hours
Interval 0.8 to 2.0
|
1.00 Hours
Interval 0.8 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3Population: This analysis was performed on PK Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Cmax of GSK3923868 for Repeat Dose
Day 1
|
14081.13 Picograms per milliliter
Geometric Coefficient of Variation 13.69
|
—
|
—
|
|
Cmax of GSK3923868 for Repeat Dose
Day 14
|
13854.60 Picograms per milliliter
Geometric Coefficient of Variation 25.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3Population: This analysis was performed on PK Population which included all randomized participants in the Safety Population who had at least 1 dose of GSK3923868 and at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Outcome measures
| Measure |
Placebo SD
n=9 Participants
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
|---|---|---|---|
|
Tmax of GSK3923868 for Repeat Dose
Day 1
|
0.95 Hours
Interval 0.8 to 2.0
|
—
|
—
|
|
Tmax of GSK3923868 for Repeat Dose
Day 14
|
1.00 Hours
Interval 0.8 to 2.0
|
—
|
—
|
Adverse Events
Placebo SD
GSK3923868 500 mcg SD
GSK3923868 1000 mcg SD
Placebo RD
GSK3923868 1500 mcg RD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SD
n=6 participants at risk
Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2.
|
GSK3923868 500 mcg SD
n=9 participants at risk
Participants received single dose of GSK3923868 500 mcg in Treatment Period 1.
|
GSK3923868 1000 mcg SD
n=9 participants at risk
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2.
|
Placebo RD
n=3 participants at risk
Participants received repeat dose of placebo matching GSK3923868 in Treatment Period 3.
|
GSK3923868 1500 mcg RD
n=9 participants at risk
Participants received repeat dose of GSK3923868 1500 mcg in Treatment Period 3.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment. AEs were reported treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER