Safety, Tolerability and Blood Sampling of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Tolerability and Pharmacokinetics of Single Doses of GSK3923868 Administered Via Dry Powder Inhaler to Healthy Participants of Chinese, Japanese and European Ancestry
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: US GSK Clinical Trials Call Center
- Phone Number: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Study Contact Backup
- Name: EU GSK Clinical Trials Call Center
- Phone Number: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Study Locations
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-
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Middlesex, United Kingdom, HA1 3UJ
- GSK Investigational Site
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessment, pulmonary function testing and laboratory tests
- Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants
- Body Mass Index (BMI) within the range of 18.0-28.0 kilograms per square meter (kg/m^2) (inclusive)
- A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Woman of non-childbearing potential (WONCBP); or Woman of childbearing potential (WOCBP) and using an acceptable contraceptive method; or A WOCBP must have a negative highly sensitive pregnancy test within 30 days before the first dose of study intervention
- Informed consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Participants of Chinese ancestry are eligible if they are born in mainland China, Hong Kong or Taiwan; descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents; have lived outside mainland China, Hong Kong or Taiwan for less than 10 years at the time of screening
- Participants of Japanese ancestry are eligible if they are born in Japan, descendent of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents; have lived outside Japan less than 10 years at the time of screening
- Participants of European ancestry are eligible if they self-identified as being European ancestry (that is, from the original people of Europe) irrespective of place of birth and current place of residence; descendent of 4 grandparents and 2 parents of European ancestry
Exclusion Criteria:
- 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
- Serum 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 less than [<] 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 greater than (>) 450 milliseconds (msec) at Screening visit based on the average of triplicate ECGs
- 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 (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study treatment, unless in the opinion of the investigator and the GSK Medical Monitor (if necessary), the medication will not interfere with the study procedures or compromise participant safety
- Recent donation of blood or blood products such that participation in this study would result in loss of blood in excess of 500 mL within a 60-day period.
- Exposure to more than 4 new chemical or molecular 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: 45 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- FEV1 <80% predicted normal value at Screening
- Presence of hepatitis B surface antigen 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
- Current or history of drug abuse
- 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 urine cotinine test indicative of recent smoking at Screening or admission to the clinical research unit
- History of regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males and females
- Sensitivity to the study intervention or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: GSK3923868
Participants from Chinese, Japanese and European ancestries will receive single dose of GSK3923868.
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Participants will receive single dose of GSK3923868.
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Placebo Comparator: Placebo
Participants from Chinese, Japanese and European ancestries will receive single dose of placebo.
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Participants will receive single dose of Placebo.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with Adverse events (AE)
Time Frame: Up to Day 14 (End of follow up)
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
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Up to Day 14 (End of follow up)
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Number of Participants with Serious Adverse events (SAE)
Time Frame: Up to Day 14 (End of follow up)
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An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcome; or is a suspected transmission of any infectious agent via an authorized medicinal product.
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Up to Day 14 (End of follow up)
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Number of Participants with Clinically Significant Changes in Laboratory Values
Time Frame: Up to Day 14 (End of follow up)
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Clinically significant changes in laboratory values (Clinical Chemistry, Haematology and Coagulation Clinical Chemistry, Haematology, and Coagulation) will be assessed.
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Up to Day 14 (End of follow up)
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Number of Participants with Clinically Significant Changes in Laboratory values
Time Frame: Up to Day 14 (End of follow up)
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Clinically significant changes in Laboratory values (Urinalysis) will be assessed.
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Up to Day 14 (End of follow up)
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Number of Participants with Clinically Significant Changes in Vital signs
Time Frame: Up to Day 14 (End of follow up)
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Clinically significant changes in Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate, pulse oximetry and oral temperature) will be assessed.
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Up to Day 14 (End of follow up)
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Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time Frame: Up to Day 14 (End of follow up)
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Clinically significant changes in 12-lead ECG will be assessed.
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Up to Day 14 (End of follow up)
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Number of Participants with Clinically Significant Changes in Spirometry Measurements
Time Frame: On Day 14 (End of follow up)
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Number of participants with clinically significant changes in Spirometry measurements.
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On Day 14 (End of follow up)
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Area Under the Plasma GSK3923868 Concentration Versus Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-t]) of GSK3923868
Time Frame: Up to Day 4
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Blood samples will be collected at the specified timepoints for the pharmacokinetics (PK) assessments.
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Up to Day 4
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Area under the Plasma GSK3923868 Concentration versus Time Curve from Time zero to Infinity (AUC[0-inf]) of GSK3923868
Time Frame: Up to Day 4
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Blood samples will be collected at the specified timepoints for the PK assessments.
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Up to Day 4
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Maximum Observed GSK3923868 Plasma Concentration (Cmax) of GSK3923868
Time Frame: Up to Day 4
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Blood samples will be collected at the specified timepoints for the PK assessments.
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Up to Day 4
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Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3923868
Time Frame: Up to Day 4
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Blood samples will be collected at the specified timepoints for the PK assessments.
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Up to Day 4
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Terminal Half-life (T1/2) of GSK3923868
Time Frame: Up to Day 4
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Blood samples will be collected at the specified timepoints for the PK assessments.
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Up to Day 4
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 218320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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