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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585009
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: GSK3923868 Drug: Matching placebo Device: Monodose RS01 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Cohort1:GSK3923868 50 micrograms (mcg)/ Placebo/ 250mcg
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 1:GSK3923868 50 mcg/ 100 mcg/ Placebo
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 1:GSK3923868 50mcg/ 100mcg/ 250mcg
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 1:Placebo / GSK3923868 100 mcg/ GSK3923868 250 mcg
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.
Drug: GSK3923868
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 2:Placebo / GSK3923868 1000 mcg/ GSK3923868 3000 mcg
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 2:GSK3923868 500 mcg/ Placebo/ 3000 mcg
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 2:GSK3923868 500 mcg/ 1000 mcg/ Placebo
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Drug: Matching placebo
Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 2:GSK3923868 500mcg/ 1000mcg/ 3000mcg
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
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 3: Participants receivings repeated doses of GSK3923868
Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Drug: GSK3923868
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 4: Participants receiving repeat doses of GSK3923868
Healthy participants will receive planned repeat doses of 3000 mcg (six capsules) GSK3923868 daily for 14 days
Drug: GSK3923868
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Experimental: Cohort 5: Participants receiving repeat doses of GSK3923868
Participants with stable asthma will receive a planned repeat dosing of 3000 mcg (six capsules) GSK3923868 daily for 7 days
Drug: GSK3923868
GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.

Device: Monodose RS01
Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.




Primary Outcome Measures :
  1. Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    AEs and SAEs will be collected.

  2. Part B: Number of participants with AEs and SAEs [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    AEs and SAEs will be collected.

  3. Part C: Number of participants with AEs and SAEs [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    AEs and SAEs will be collected.

  4. Part A: Number of participants with clinically significant changes in hematology lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the assessment of hematology laboratory (lab) parameters.

  5. Part A: Number of participants with clinically significant changes in clinical chemistry lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the assessment of clinical chemistry lab parameters.

  6. Part A: Number of participants with clinically significant changes in urinalysis lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Urine samples will be collected for the assessment of urinalysis lab parameters.

  7. Part B: Number of participants with clinically significant changes in hematology lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Blood samples will be collected for the assessment of hematology lab parameters.

  8. Part B: Number of participants with clinically significant changes in clinical chemistry lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Blood samples will be collected for the assessment of clinical chemistry lab parameters.

  9. Part B: Number of participants with clinically significant changes in urinalysis lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Urine samples will be collected for the assessment of urinalysis lab parameters.

  10. Part C: Number of participants with clinically significant changes in hematology lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Blood samples will be collected for the assessment of hematology lab parameters.

  11. Part C: Number of participants with clinically significant changes in clinical chemistry lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Blood samples will be collected for the assessment of clinical chemistry lab parameters.

  12. Part C: Number of participants with clinically significant changes in urinalysis lab parameters [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Urine samples will be collected for the assessment of urinalysis lab parameters.

  13. Part A: Number of participants with clinically significant vital signs [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.

  14. Part B: Number of participants with clinically significant vital signs [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.

  15. Part C: Number of participants with clinically significant vital signs [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.

  16. Part A: Number of participants with clinically significant abnormalities in 12-Lead electrocardiogram (ECG) findings [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT intervals (QTc). The QT interval will be corrected for heart rate by Fredericia's formula (QTcF).

  17. Part B: Number of participants with clinically significant abnormalities in 12-Lead ECG findings [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.

  18. Part C: Number of participants with clinically significant abnormalities in 12-Lead ECG findings [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.

  19. Part A: Number of participants with clinically significant abnormalities in spirometry measurements [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Spirometry measurements including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be assessed

  20. Part B: Number of participants with clinically significant abnormalities in spirometry measurements [ Time Frame: From start of the treatment (Day 0) to Day 18 ]
    Spirometry measurements including FEV1 and FVC will be assessed.

  21. Part C: Number of participants with clinically significant abnormalities in spirometry measurements [ Time Frame: From start of the treatment (Day 0) to Day 8 ]
    Spirometry measurements including FEV1 and FVC will be assessed.


Secondary Outcome Measures :
  1. 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: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the concentrations of GSK3923868.

  2. 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: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the concentration of GSK3923868.

  3. Part A, Cohort 1 and 2: Maximum observed GSK3923868 plasma concentration (Cmax) [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the concentrations of GSK3923868.

  4. Part A, Cohort 1 and 2: Time to maximum observed plasma drug concentration (Tmax) [ Time Frame: From start of the treatment (Day 0) to Day 2 in each treatment period ]
    Blood samples will be collected for the concentrations of GSK3923868.

  5. Part B, Cohort 3 and 4: AUC from time 0 (predose) to time tau (AUC [0-tau]) (tau=24hours for once a day dosing regimen) of GSK3923868 on Day 1 and Day 14 [ Time Frame: Day 1 and 14: Up to 24 hours post dose ]
    Blood samples will be collected for the concentrations of GSK3923868.

  6. Part B, Cohort 3 and 4: Cmax of GSK3923868 on Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 ]
    Blood samples will be collected for the concentrations of GSK3923868.

  7. Part B, Cohort 3 and 4: Tmax of GSK3923868 on Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 ]
    Blood samples will be collected for the concentrations of GSK3923868.

  8. Part C: AUC (0-tau) (tau=24hours for once a day dosing regimen)of GSK3923868 on Day 1 and Day 7 [ Time Frame: Day 1 and 7: Up to 24 hours post dose ]
    Blood samples will be collected for the concentrations of GSK3923868.

  9. Part C: Cmax of GSK3923868 on Day 1 and Day 7 [ Time Frame: Day 1 and Day 7 ]
    Blood samples will be collected for the concentrations of GSK3923868.

  10. Part C: Tmax of GSK3923868 on Day 1 and Day 7 [ Time Frame: Day 1 and Day 7 ]
    Blood samples will be collected for the concentrations of GSK3923868.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585009


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United Kingdom
GSK Investigational Site Recruiting
Cambridge, United Kingdom, CB2 2GG
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edward Banham-Hall         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04585009    
Other Study ID Numbers: 213497
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: 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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
First time in human
Stable asthmatics
GSK3923868
Inhalation powder
Phosphatidylinositol 4-kinase beta
Additional relevant MeSH terms:
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Respiratory Aspiration
Asthma
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases