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This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | Experimental | Eligible participants will receive 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 will also receive a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868. |
|
| GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | Experimental | Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868. |
|
| GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Experimental | Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868. |
|
| Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3923868 | Drug | GSK3923868 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868 | 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. | Up to 18 days |
| Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868 | 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. | Up to 29 days |
| Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Berlin | 14050 | Germany |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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All the 12 participants were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (3 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2022 | Jul 17, 2024 |
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The same cohort of participants will move from Part 1 (single ascending doses treatment periods 1 and 2) to Part 2 (repeat dose treatment period 3)
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The participants and investigators will be blinded.
Eligible participants will receive a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868. |
|
| Placebo | Drug | Placebo will be administered |
|
| Up to 18 days |
| Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868 | 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. | Up to 29 days |
| Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868 | 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. | Up to 29 days |
| Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868 | 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. | Up to 18 days |
| Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868 | 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. | Up to 29 days |
| Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868 | 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. | Up to 18 days |
| Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868 | 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. | Up to 29 days |
| 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 | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
| Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
| Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
| Cmax of GSK3923868 for Repeat Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
| Tmax of GSK3923868 for Repeat Dose | 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. | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (up to 6 Days) |
|
| Treatment Period 2 (3 Days) |
|
| Washout Period 2 (up to 6 Days) |
|
| Treatment Period 3 (up to 15 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||
| Sex/Gender, Customized | Gender categories (with 0\ | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race categories (with 0\ | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 days |
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| Primary | Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 29 days |
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| Primary | Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 29 days |
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| Primary | Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 29 days |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 days |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 29 days |
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| Primary | Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 18 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868 | 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. | This analysis was performed on Safety Population which included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 29 days |
|
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| Secondary | Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose | 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. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* picograms per milliliter | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
|
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| Secondary | 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 | 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. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* picograms per milliliter | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
|
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| Secondary | Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* picograms per milliliter | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
|
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose | 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. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | Picograms per milliliter | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
|
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| Secondary | Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose | 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. | 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). | Posted | Median | Full Range | Hours | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2 |
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| Secondary | Cmax of GSK3923868 for Repeat Dose | 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. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | Picograms per milliliter | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
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| Secondary | Tmax of GSK3923868 for Repeat Dose | 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. | 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). | Posted | Median | Full Range | Hours | Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3 |
|
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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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo SD | Participants received single dose of placebo matching GSK3923868 in Treatment Periods 1 and 2. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | GSK3923868 500 mcg SD | Participants received single dose of GSK3923868 500 mcg in Treatment Period 1. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | GSK3923868 1000 mcg SD | Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Placebo RD | Participants received repeat dose of placebo matching GSK3923868 in Treatment Period 3. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG004 | GSK3923868 1500 mcg RD | Participants received repeat dose of GSK3923868 1500 mcg in Treatment Period 3. | 0 | 9 | 0 | 9 | 4 | 9 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2023 | Jul 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2. |
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| GSK3923868 1000 mcg SD |
Participants received single dose of GSK3923868 1000 mcg in Treatment Period 2. |
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