Pulmonary Disease, Chronic ObstructivePhase 1NCT04585009

Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics

A Phase 1 study testing GSK3923868 and Monodose RS01 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: GSK3923868 and Monodose RS01
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Oct 2020to 16 Jun 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

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

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.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: GSK3923868, Matching placebo, Monodose RS01
Keywords: First time in human, Stable asthmatics, GSK3923868, Inhalation powder, Phosphatidylinositol 4-kinase beta
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK3923868Drug
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
Matching placeboDrug
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.
Monodose RS01Device
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Study groups in NCT04585009
Study group	Role	What they receive
Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg	Experimental	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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: Drug: GSK3923868; Device: Monodose RS01

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: Up to Day 28
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of the treatment (Day 1) to Day 8

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202016 Jun 2022

First posted14 Oct 2020
Study start12 Oct 2020
Primary completion16 Jun 2022
Study completion16 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585009
Sponsor's protocol ID: 213497
Status last verified: Jun 2023
First submitted: 9 Oct 2020
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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The sponsor has not listed a contact. The official record may have more details.

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Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04585009
Acronym / sponsor ID: 213497
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: First time in human, Stable asthmatics, GSK3923868, Inhalation powder, Phosphatidylinositol 4-kinase beta
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Oct 2020 (actual)
Primary completion: 16 Jun 2022 (actual)
Study completion: 16 Jun 2022 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 20 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 11
Model description: 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.

Arm	Type	Receives
Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg	Experimental	Drug: GSK3923868, Device: Monodose RS01Healthy 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.
Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo	Experimental	Drug: GSK3923868, Drug: Matching placebo, Device: Monodose RS01Healthy 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.
Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg	Experimental	Drug: GSK3923868, Device: Monodose RS01Healthy 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.
Cohort 3: Participants receivings repeated doses of GSK3923868	Experimental	Drug: GSK3923868, Device: Monodose RS01Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Cohort 4: Participants receiving repeat doses of GSK3923868	Experimental	Drug: GSK3923868, Device: Monodose RS01Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Cohort 5: Participants receiving repeat doses of GSK3923868	Experimental	Drug: GSK3923868, Device: Monodose RS01Participants with stable asthma will receive a planned repeat dosing of 3000 mcg (six capsules) GSK3923868 daily for 7 days

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

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).

Key exclusion criteria (54 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK3923868GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.	Drug	Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo, 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, Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg
Matching placeboPlacebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.	Drug	Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo, 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:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg, Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg
Monodose RS01Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.	Device	Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo, 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, Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg

Primary outcome

Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 43
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.
Part A, Cohort 2: Number of Participants With AEs and SAEs
Time frame: Up to Day 43
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.
Part B: Number of Participants With AEs and SAEs
Time frame: Up to Day 28
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).
Part C: Number of Participants With AEs and SAEs
Time frame: Up to Day 21
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.
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Time frame: From start of the treatment (Day 1) to Day 18
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.
Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Time frame: From start of the treatment (Day 1) to Day 8
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.
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Time frame: From start of the treatment (Day 1) to Day 18
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.
Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Time frame: From start of the treatment (Day 1) to Day 8
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.
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Time frame: From start of the treatment (Day 1) to Day 2 in each treatment period
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.
Part B: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Time frame: From start of the treatment (Day 1) up to Day 18
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.
Part C: Number of Participants With Clinically Significant Changes in Spirometry Measurements
Time frame: From start of the treatment (Day 1) to Day 8
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.

10 secondary outcomes

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])
Time frame: 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])
Time frame: Up to Day 2 in each treatment period
Part A, Cohort 1 and 2: Maximum Observed GSK3923868 Plasma Concentration (Cmax)
Time frame: Up to Day 2 in each treatment period
Part A, Cohort 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Time frame: 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
Time frame: Up to Day 14
Part B, Cohort 3 and 4: Cmax of GSK3923868
Time frame: Up to Day 14
Part B, Cohort 3 and 4: Tmax of GSK3923868
Time frame: Up to Day 14
Part C: AUC (0-tau) (Tau=24 Hours for Once a Day Dosing Regimen) of GSK3923868
Time frame: Up to Day 7
Part C: Cmax of GSK3923868
Time frame: Up to Day 7
Part C: Tmax of GSK3923868
Time frame: Up to Day 7

Results and safety

Results posted to the registry on 20 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: GSK3923868 50 Micrograms (mcg)/ Placebo/ 250mcg	3	2
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo	3	3
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg	3	3
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg	3	3
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg	0	0
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg	0	0
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo	0	0
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg	0	0
Cohort 3 and 4: Placebo	0	0
Cohort 3 and 4: GSK3923868 3000mcg	0	0
Cohort 5: Placebo	0	0
Cohort 5: GSK3923868 3000mcg	0	0

Primary outcome: Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to Day 43. Count of participants. Unit: Participants

Measure	Cohort 1: Placebo n = 9	Cohort 1: GSK3923868 50 mcg n = 9	Cohort 1: GSK3923868 100 mcg n = 9	Cohort 1: GSK3923868 250mcg n = 9
AEs	3	3	3	6
SAEs	0	0	0	0

Population analysed: 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.

Primary outcome: Part A, Cohort 2: Number of Participants With AEs and SAEs

Time frame: Up to Day 43. Count of participants. Unit: Participants

Measure	Cohort 2: Placebo n = 9	Cohort 2: GSK3923868 500 mcg n = 9	Cohort 2: GSK3923868 1000 mcg n = 9	Cohort 2: GSK3923868 3000mcg n = 9
AEs	5	5	5	3
SAEs	0	0	0	0

Primary outcome: Part B: Number of Participants With AEs and SAEs

Time frame: Up to Day 28. Count of participants. Unit: Participants

Measure	Cohort 3 and 4: Placebo n = 4	Cohort 3 and 4: GSK3923868 3000mcg n = 13
AEs	4	12
SAEs	0	0

Primary outcome: Part C: Number of Participants With AEs and SAEs

Time frame: Up to Day 21. Count of participants. Unit: Participants

Measure	Cohort 5: Placebo n = 3	Cohort 5: GSK3923868 3000mcg n = 8
AEs	3	8
SAEs	0	0

10 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Placebo	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 1: GSK3923868 50 mcg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 1: GSK3923868 100 mcg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 1: GSK3923868 250mcg	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Cohort 2: Placebo	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Cohort 2: GSK3923868 500 mcg	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Cohort 2: GSK3923868 1000 mcg	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Cohort 2: GSK3923868 3000mcg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 3 and 4: Placebo	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 3 and 4: GSK3923868 3000mcg	0 of 13 (0%)	12 of 13 (92.3%)	0 of 13
Cohort 5: Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 5: GSK3923868 3000mcg	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3923868 and Monodose RS01 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 43). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.