Safety, Tolerability and Pharmacokinetics of GSK3923868 I... | NCT04585009 | Trialant
NCT04585009
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Feb 20, 2024Actual
Enrollment
56Actual
Phase
Phase 1
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
GSK3923868
Matching placebo
Monodose RS01
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04585009
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213497
Secondary IDs
Not provided
Brief Title
Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics
Official Title
A Randomised Double-blind, Placebo Controlled, Single Ascending and Repeat Dose, First Time in Human Study in Healthy Participants and Stable Asthmatics to Assess Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 12, 2020Actual
Primary Completion Date
Jun 16, 2022Actual
Completion Date
Jun 16, 2022Actual
First Submitted Date
Oct 9, 2020
First Submission Date that Met QC Criteria
Oct 9, 2020
First Posted Date
Oct 14, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2023
Results First Submitted that Met QC Criteria
Jun 16, 2023
Results First Posted Date
Feb 20, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 16, 2023
Last Update Posted Date
Feb 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo
Experimental
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg
Experimental
Healthy participants will receive single ascending doses of GSK3923868 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Device: Monodose RS01
Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg
Experimental
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There will be at least 10 days of wash-out period between doses for each participant.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3923868
Drug
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-1 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
Up to Day 43
Part A, Cohort 2: Number of Participants With AEs and SAEs
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-2 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
Up to Day 43
Part B: Number of Participants With AEs and SAEs
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part B, Cohort-3 and 4 (repeat dose) of the study were reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Up to Day 28
Secondary Outcomes
Measure
Description
Time Frame
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-t])
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported. Single ascending doses of GSK3923868 were assessed in 2 sequential crossover cohorts (Cohorts 1 and 2) of healthy participants, each with up to 3 treatment periods.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: For Parts A and B
Between 18 and 50 years of age inclusive, at the time of signing the informed consent.
Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, laboratory tests and cardiac monitoring.
Body weight at least 50.0 kilograms (kg) (110 pounds [lbs]) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per meter square (kg/m^2) (inclusive).
Male Participants: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of study intervention: Refrain from donating sperm. Plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remaining abstinent OR must agree to use contraception as detailed below when having sexual intercourse with a woman of childbearing potential who is not currently pregnant: Agree to use a male condom AND female partner to use an additional highly effective contraceptive method with a failure rate of < 1 percent per year. The participant should also be advised of the benefit for a female partner as a condom may break or leak.
Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a woman of non-childbearing potential (WONCBP).
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
Inclusion Criteria: Part C
Between 18 and 50 years of age inclusive, at the time of signing the informed consent.
Participants who are otherwise healthy (other than the acceptable condition of asthma and other mild atopic diseases, including allergic rhinitis and atopic dermatitis) as determined by medical evaluation based on screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, laboratory tests and cardiac monitoring.
A physician diagnosis of asthma (as defined by the Global Initiative for Asthma [GINA], 2020 guidelines) at least 6 months before screening. The reason for diagnosis of asthma should be documented in the participant's source data, including relevant history.
A screening pre-bronchodilator FEV1 >= 65 percent predicted normal value.
Positive bronchodilator reversibility test defined as an increase in FEV1 of > 12 percent and > 200 milliliter (mL) from Baseline, 10 to 15 minutes after administration of 400 micrograms (μg) salbutamol (or equivalent).
Participants with maintained control of their asthma using the permitted medications: short-acting beta agonist (SABA) use only (n=8 participants) and regular treatment with inhaled corticosteroid (ICS) or ICS/long-acting beta agonist (LABA) (including use of Leukotriene Receptor Agonist [LTRA]) (n=8 participants).
Body weight at least 50.0 kg (110 lbs) and BMI within the range 18.5 to 32.0 kg/m^2 (inclusive).
Male Participants: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remaining abstinent OR must agree to use contraception as detailed below when having sexual intercourse with a woman of childbearing potential who is not currently pregnant: Agree to use a male condom AND female partner to use an additional highly effective contraceptive method with a failure rate of < 1 percent per year. The participant should also be advised of the benefit for a female partner as a condom may break or leak.
Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a WONCBP.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria: Part A and B
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
Alanine transaminase (ALT) and Aspartate Aminotransferase (AST) above upper limit of normal (ULN).
Total Bilirubin above ULN (isolated bilirubin above ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35 percent).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QTcF > 450 milliseconds (msec) at screening visit based on the average of triplicate ECGs.
Screening ECG measurements meets the following criteria for exclusion: heart rate: males- <45 or > 100 beats per minute (bpm); females- <50 or > 100 bpm; PR interval: <120 or >220 msec; QRS duration: <70 or >120 msec; QTcF: >450 msec.
Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
Evidence of previous myocardial infarction (does not include ST segment changes associated with re-polarization).
Signs and symptoms suggestive of COVID-19.
Past or intended use of over-the-counter or prescription medication, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days before the first dose of study intervention, unless in the opinion of the Investigator and the GlaxoSmithKline (GSK) Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety.
Participation in this study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days.
Exposure to more than 4 new chemical entities within 12 months before the first dosing day.
Current enrolment or past participation in a clinical trial and has received an investigational product within the following time period before the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
FEV1 and FVC is < 80 percent predicted normal value.
Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Positive test for COVID-19 infection.
Current or history of drug abuse.
Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular (AV) block [2nd degree or higher], Wolff-Parkinson-White (WPW) syndrome).
Sinus Pauses > 3 seconds.
Any significant arrhythmia which, in the opinion of the Investigator or GSK Medical monitor, will interfere with the safety for the individual participant.
Non-sustained or sustained ventricular tachycardia (with more than 3 consecutive ventricular ectopic beats).
Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 14 units for both males and females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Current or previous use of tobacco- or nicotine-containing products (e.g. cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of > 5 pack years.
Positive breath carbon monoxide test indicative of recent smoking at screening or each in-house admission to the clinical research unit.
Sensitivity to any of the study interventions, or components thereof (including lactose and magnesium stearate [MgSt]), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Participants with known COVID-19 positive contacts in the past 14 days.
Exclusion criteria: Part C
Any asthma exacerbation requiring systemic corticosteroids within 8 weeks of screening, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of screening.
A history of life-threatening asthma, defined as an any asthma episode that required admission to a high-dependency or intensive therapy unit.
Significant pulmonary diseases, other than asthma, including (but not limited to): pneumonia previously requiring hospital admission, bronchiectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other significant respiratory abnormalities.
ALT and AST above ULN.
Bilirubin above ULN (isolated bilirubin above ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QTcF > 450 msec at screening visit based on the average of triplicate ECGs.
Signs and symptoms suggestive of COVID-19.
Past or intended use of over-the-counter or prescription medication, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days before the first dose of study intervention, unless in the opinion of the Investigator and the GSK Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety.
Participation in this study would result in loss of blood or blood products in excess of 500 mL within 56 days.
Exposure to more than 4 new chemical entities within 12 months before the first dosing day.
Current enrolment or past participation in a clinical trial and has received an investigational product within the following time period before the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Presence of HBsAg at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
Positive pre-study drug/alcohol screen.
Positive HIV antibody test.
Positive test for COVID-19 infection.
Current or history of drug abuse.
Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 14 units for males and females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Current or previous use of tobacco- or nicotine-containing products (e.g. cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of > 5 pack years.
Positive breath carbon monoxide test indicative of recent smoking at screening or each in-house admission to the clinical research unit.
Sensitivity to any of the study interventions, or components thereof (including lactose and MgSt), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Participants with known COVID-19 positive contacts in the past 14 days.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Cambridge
CB2 2GG
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria
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.
A total of 56 participants (28 in Part A ,17 in Part B and 11 in Part C) were enrolled in this study. This study was conducted at a single center in the United Kingdom.
Recruitment Details
This was a three-part study with single dose escalation in Part A and repeat dose in Part B and C. Part A and B was conducted in healthy volunteers and Part C was conducted in participants with asthma.
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
FG001
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
FG002
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
FG003
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day1 in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
FG004
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
FG005
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
FG006
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
FG007
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
FG008
Cohort 3 and 4: Placebo
Healthy participants received placebo matched to GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
FG009
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
FG010
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
FG011
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Periods
Title
Milestones
Reasons Not Completed
PartA, Cohort1, Treatment Period1(Day1)
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
COMPLETED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Cohort1: Washout Period1 (10Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG003
PartA, Cohort1,Treatment Period2(Day1)
Type
Comment
Milestone Data
STARTED
FG0003 subjectsOne new participant enrolled and dosed.
FG0013 subjects
FG0023 subjects
FG003
Cohort1: Washout Period2(10 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG003
PartA, Cohort1, Treatment Period3(Day1)
Type
Comment
Milestone Data
STARTED
FG0003 subjectsOne new participant enrolled and dosed.
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
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
Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-1 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
Up to Day 43
ID
Title
Description
OG000
Cohort 1: Placebo
Adverse Events Module
Frequency Threshold
0
Time Frame
All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Description
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Placebo
Healthy participants received a single dose (SD) of placebo in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Part A will be a single ascending dose escalation study consisting of two sequential cross-over cohorts (Cohorts 1 and 2) in healthy participants. Part B is a repeat dose study consisting of two parallel cohorts (Cohort 3 and 4) in healthy participants. Part C is a repeat dose study consisting of one cohort (Cohort 5) in participants with asthma.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg
Experimental
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg
Experimental
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo
Experimental
Healthy participants will receive single ascending doses of GSK3923868 or placebo in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Drug: Matching placebo
Device: Monodose RS01
Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg
Experimental
Healthy participants will receive single ascending doses of GSK3923868 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg. There will be at least 10 days of wash-out period between doses for each participant.
Drug: GSK3923868
Device: Monodose RS01
Cohort 3: Participants receivings repeated doses of GSK3923868
Experimental
Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Drug: GSK3923868
Device: Monodose RS01
Cohort 4: Participants receiving repeat doses of GSK3923868
Experimental
Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Drug: GSK3923868
Device: Monodose RS01
Cohort 5: Participants receiving repeat doses of GSK3923868
Experimental
Participants with stable asthma will receive a planned repeat dosing of 3000 mcg (six capsules) GSK3923868 daily for 7 days
Drug: GSK3923868
Device: Monodose RS01
Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg
Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg
Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo
Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg
Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg
Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg
Cohort 3: Participants receivings repeated doses of GSK3923868
Cohort 4: Participants receiving repeat doses of GSK3923868
Cohort 5: Participants receiving repeat doses of GSK3923868
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part C, Cohort-5 (repeat dose) of the study were reported.
Up to Day 21
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 18
Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 8
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-1 were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-2 were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 18
Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-5 were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 8
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 2 in each treatment period
Part B: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) up to Day 18
Part C: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
From start of the treatment (Day 1) to Day 8
Up to Day 2 in each treatment period
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf])
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero extrapolated to infinite time values were reported.
Up to Day 2 in each treatment period
Part A, Cohort 1 and 2: Maximum Observed GSK3923868 Plasma Concentration (Cmax)
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Up to Day 2 in each treatment period
Part A, Cohort 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Up to Day 2 in each treatment period
Part B, Cohort 3 and 4: AUC From Time Zero (Predose) to Time Tau (AUC [0-tau]) (Tau=24hours for Once a Day Dosing Regimen) of GSK3923868
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Area under the concentration-time curve from time zero (predose) to time tau (dosing interval) was reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Up to Day 14
Part B, Cohort 3 and 4: Cmax of GSK3923868
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Up to Day 14
Part B, Cohort 3 and 4: Tmax of GSK3923868
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Up to Day 14
Part C: AUC (0-tau) (Tau=24 Hours for Once a Day Dosing Regimen) of GSK3923868
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Up to Day 7
Part C: Cmax of GSK3923868
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Up to Day 7
Part C: Tmax of GSK3923868
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Up to Day 7
0 subjects
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Reasons
Adverse Event
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BG001
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
BG002
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
BG003
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day1 in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
BG004
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
BG005
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
BG006
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
BG007
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
BG008
Cohort 3 and 4: Placebo
Healthy participants received placebo matched to GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
BG009
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
BG010
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
BG011
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
BG012
Total
Total of all reporting groups
5
BG0013
BG0023
BG0033
BG0044
BG0053
BG0063
BG0074
BG0084
BG00913
BG0103
BG0118
BG01256
Participants
Title
Denominators
Categories
Title
Measurements
<=18
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
19-64
BG0005
BG0013
BG0023
BG0033
BG004
>=65
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
Male
BG0005
BG0013
BG0023
BG0033
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ASIAN
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0101
BG0110
BG0124
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0000
BG0010
BG0020
BG003
WHITE
Title
Measurements
BG0003
BG0013
BG0022
BG003
MIXED RACE
Title
Measurements
BG0001
BG0010
BG0020
BG003
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0013
OG0023
OG0036
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A, Cohort 2: Number of Participants With AEs and SAEs
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-2 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
Up to Day 43
ID
Title
Description
OG000
Cohort 2: Placebo
Healthy participants received a SD of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0005
OG0015
OG0025
OG003
Primary
Part B: Number of Participants With AEs and SAEs
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part B, Cohort-3 and 4 (repeat dose) of the study were reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
Up to Day 28
ID
Title
Description
OG000
Cohort 3 and 4: Placebo
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0004
OG00113
Title
Denominators
Categories
AEs
Title
Measurements
OG0004
OG00112
SAEs
Title
Measurements
OG000
Primary
Part C: Number of Participants With AEs and SAEs
AEs and SAEs were collected. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part C, Cohort-5 (repeat dose) of the study were reported.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
Up to Day 21
ID
Title
Description
OG000
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0018
SAEs
Title
Measurements
OG000
Primary
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: Placebo
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Clinical Chemistry
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
The analysis was performed on the Safety Set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 2: Placebo
Healthy participants received a SD of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Clinical Chemistry
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 18
ID
Title
Description
OG000
Cohort 3 and 4: Placebo
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0004
OG00113
Title
Denominators
Categories
Clinical Chemistry
Title
Measurements
OG0001
OG0010
Hematology
Title
Measurements
OG000
Primary
Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 8
ID
Title
Description
OG000
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Clinical Chemistry
Title
Measurements
OG0001
OG0011
Hematology
Title
Measurements
OG000
Primary
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-1 were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: Placebo
Healthy participants received a single dose (SD) of placebo in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Vital Signs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-2 were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 2: Placebo
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Vital Signs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 18
ID
Title
Description
OG000
Cohort 3 and 4: Placebo
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0004
OG00113
Title
Denominators
Categories
Vital Signs
Title
Measurements
OG0001
OG0016
12-Lead ECG
Title
Measurements
OG000
Primary
Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. 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 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 parameters for cohort-5 were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 8
ID
Title
Description
OG000
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Vital Signs
Title
Measurements
OG0000
OG0010
12-Lead ECG
Title
Measurements
OG000
Primary
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: Placebo
Healthy participants received a single dose (SD) of placebo in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
The analysis was performed on the Safety Set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 2: Placebo
Healthy participants received a SD of placebo in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG002
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG003
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) up to Day 18
ID
Title
Description
OG000
Cohort 3 and 4: Placebo
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0004
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Part C: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
From start of the treatment (Day 1) to Day 8
ID
Title
Description
OG000
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
OG001
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Secondary
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-t])
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported. Single ascending doses of GSK3923868 were assessed in 2 sequential crossover cohorts (Cohorts 1 and 2) of healthy participants, each with up to 3 treatment periods.
The analysis was performed on the Pharmacokinetic (PK) Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*Picograms Per Milliliter (h*pg/mL)
Up to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
OG001
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
OG002
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
OG003
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
OG004
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
OG005
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0001774.65± 48.78
OG0013810.3± 39.08
OG0028111.1± 33.37
OG003
Secondary
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf])
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero extrapolated to infinite time values were reported.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*pg/mL
Up to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG001
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG002
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG003
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG004
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG005
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0001964.21± 50.59
OG0014125.22± 40.59
OG0028656.56± 34.71
OG003
Secondary
Part A, Cohort 1 and 2: Maximum Observed GSK3923868 Plasma Concentration (Cmax)
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms Per Milliliter (pg/mL)
Up to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG001
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG002
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG003
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG004
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG005
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000370.84± 37.29
OG001772.49± 29.19
OG0021811.8± 27.96
OG003
Secondary
Part A, Cohort 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Posted
Median
Full Range
Hour (h)
Up to Day 2 in each treatment period
ID
Title
Description
OG000
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG001
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG002
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG003
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG004
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
OG005
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout of at least 10 days was maintained between treatment periods.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0001(1 to 2)
OG0011(1 to 2)
OG0021(0.8 to 1)
OG003
Secondary
Part B, Cohort 3 and 4: AUC From Time Zero (Predose) to Time Tau (AUC [0-tau]) (Tau=24hours for Once a Day Dosing Regimen) of GSK3923868
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Area under the concentration-time curve from time zero (predose) to time tau (dosing interval) was reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*pg/mL
Up to Day 14
ID
Title
Description
OG000
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days.
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Day 1
ParticipantsOG00013
Title
Measurements
OG000128045.03± 31.39
Day 14 (n=12)
ParticipantsOG000
Secondary
Part B, Cohort 3 and 4: Cmax of GSK3923868
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
Up to Day 14
ID
Title
Description
OG000
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Day 1
ParticipantsOG00013
Title
Measurements
OG00032342.47± 24
Day 14 (n=12)
ParticipantsOG000
Secondary
Part B, Cohort 3 and 4: Tmax of GSK3923868
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Posted
Median
Full Range
Hour (h)
Up to Day 14
ID
Title
Description
OG000
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Day 1
ParticipantsOG00013
Title
Measurements
OG0000.75(0.75 to 1)
Day 14 (n=12)
ParticipantsOG000
Secondary
Part C: AUC (0-tau) (Tau=24 Hours for Once a Day Dosing Regimen) of GSK3923868
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*pg/mL
Up to Day 7
ID
Title
Description
OG000
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days
Units
Counts
Participants
OG0008
Title
Denominators
Categories
Day 1
ParticipantsOG0008
Title
Measurements
OG00097412.11± 39.87
Day 7 (n=7)
ParticipantsOG000
Secondary
Part C: Cmax of GSK3923868
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
Up to Day 7
ID
Title
Description
OG000
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days
Units
Counts
Participants
OG0008
Title
Denominators
Categories
Day 1
ParticipantsOG0008
Title
Measurements
OG00027799.34± 25.2
Day 7 (n=7)
ParticipantsOG000
Secondary
Part C: Tmax of GSK3923868
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Posted
Median
Full Range
Hour (h)
Up to Day 7
ID
Title
Description
OG000
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days
Units
Counts
Participants
OG0008
Title
Denominators
Categories
Day 1
ParticipantsOG0008
Title
Measurements
OG0000.758(0.5 to 1)
Day 7 (n=7)
ParticipantsOG000
0
9
0
9
3
9
EG001
Cohort 1: GSK3923868 50 mcg
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
3
9
EG002
Cohort 1: GSK3923868 100 mcg
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
3
9
EG003
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
6
9
EG004
Cohort 2: Placebo
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
5
9
EG005
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
5
9
EG006
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
5
9
EG007
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
9
0
9
3
9
EG008
Cohort 3 and 4: Placebo
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
4
0
4
4
4
EG009
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
13
0
13
12
13
EG010
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
3
0
3
3
3
EG011
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
0
8
0
8
8
8
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Palpitations
Cardiac disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Abdominal pain upper
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Change of bowel habit
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
Diarrhoea
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Lip haemorrhage
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Nausea
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Chest discomfort
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected13 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected8 at risk
Chills
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0082 events2 affected4 at risk
EG0095 events5 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Fatigue
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Feeling hot
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0094 events4 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Medical device site dermatitis
General disorders
v25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Pain
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Pyrexia
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Vessel puncture site bruise
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
Hypertransaminasaemia
Hepatobiliary disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
Seasonal allergy
Immune system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
COVID-19
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
Hordeolum
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Urinary tract infection
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Muscle strain
Injury, poisoning and procedural complications
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Aspartate aminotransferase inc
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Blood creatine phosphokinase i
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Body temperature increased
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Hepatic enzyme increased
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected8 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Back pain
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Myalgia
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Dizziness
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Dysgeusia
Nervous system disorders
v25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0013 events3 affected9 at risk
EG0023 events3 affected9 at risk
EG0033 events3 affected9 at risk
EG0041 events1 affected9 at risk
EG0052 events2 affected9 at risk
EG0063 events3 affected9 at risk
EG0072 events2 affected9 at risk
EG0081 events1 affected4 at risk
EG0095 events5 affected13 at risk
EG0100 events0 affected3 at risk
EG0117 events7 affected8 at risk
Headache
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected9 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected9 at risk
EG0083 events3 affected4 at risk
EG0097 events7 affected13 at risk
EG0101 events1 affected3 at risk
EG0113 events3 affected8 at risk
Lethargy
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Sensory disturbance
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Taste disorder
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected9 at risk
EG0052 events2 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0094 events4 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Product after taste
Product Issues
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected13 at risk
EG0101 events1 affected3 at risk
EG0111 events1 affected8 at risk
Product taste abnormal
Product Issues
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0081 events1 affected4 at risk
EG0093 events3 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected9 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected13 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected8 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
v25.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG0033 events3 affected9 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected9 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected13 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected8 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.