Study to evaluate safety, tolerability and pharmacokinetics of GSK2269557 to Japanese healthy subjects
Trial overview
Number of subjects with any adverse event(s) (AE) and serious adverse event(s) (SAE)
Timeframe: Approximately up to 37 days
Session 1: Number of subjects having abnormal clinical laboratory parameters as a measure of safety
Timeframe: Approximately up to 4 days
Session 2: Number of subjects having abnormal clinical laboratory parameters as a measure of safety
Timeframe: Approximately up to 22 days
Session 1:Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Timeframe: Approximately up to 4 days
Session 2: Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Timeframe: Approximately up to 22 days
Session 1: Number of subjects having abnormal urinalysis as a measure of safety
Timeframe: Approximately up to 4 days
Session 2: Number of subjects having abnormal urinalysis as a measure of safety
Timeframe: Approximately up to 22 days
Session 1: Body temperature assessment as a safety measure
Timeframe: Approximately up to 4 days
Session 2: Body temperature assessment as a safety measure
Timeframe: Approximately up to 22 days
Session 1: Blood pressure assessment as a safety measure
Timeframe: Approximately up to 4 days
Session 2: Blood pressure assessment as a safety measure
Timeframe: Approximately up to 22 days
Session 1: Measurement of pulse rate as a safety measure
Timeframe: Approximately up to 4 days
Session 2: Measurement of pulse rate as a safety measure
Timeframe: Approximately up to 22 days
Session 1: Electrocardiogram (ECG) assessment as a measure of safety.
Timeframe: Approximately up to 4 days
Session 2: ECG assessment as a measure of safety.
Timeframe: Approximately up to 22 days
Session 1: Spirometry assessment as a safety measure
Timeframe: Approximately up to 4 days
Session 2: Spirometry assessment as a safety measure
Timeframe: Approximately up to 22 days
Session 1: Area under the plasma concentration curve (AUC) from time zero to the time of last quantifiable concentration [AUC(0-t)]
Timeframe: Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72hours (h) post-dose
Session 1: AUC from time zero to 24 hours post dose [AUC(0-24)] of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 1: AUC from time zero to infinity [AUC(0-infinity)] of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 2: AUC from time zero to the time of last quantifiable concentration [AUC(0-t)] of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 2: AUC from time zero to 24 hours post dose [AUC(0-24)] of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 2: AUC from time zero to infinity [AUC(0-infinity)] of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 1: Trough observed plasma drug concentration (Ctrough) of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 1: Maximum observed plasma concentration (Cmax) of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 1: Maximum/trough observed plasma drug concentration (Cmax/Ctrough) of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 2: Trough observed plasma drug concentration (Ctrough) of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 2: Maximum observed plasma concentration (Cmax) of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 2: Maximum/trough observed plasma drug concentration (Cmax/Ctrough) of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 1: Time to maximum observed plasma drug concentration (Tmax) of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 1: Terminal half-life (t1/2) of GSK2269557 following a single dose administration
Timeframe: Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose
Session 2: Time to maximum observed plasma drug concentration (Tmax) of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Session 2: Terminal half-life (t1/2) of GSK2269557 following repeat dose administration
Timeframe: Day 1: pre-dose, 5 min and 24 h post-dose; Day 2: 5 min post-dose; Days 3, 4, 5, 6, 7, 8, and 9: pre-dose and 5 min post-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h post-dose; 24 h, 48 h, 72 h, 96 h and 120 h post-Day 10 dose
Ratio of accumulation factor (Ro) of GSK2269557 following single and repeat inhalations
Timeframe: Day 1 of session 2 and day 10 of session 2
Ratio of accumulation factor (Rs) of GSK2269557 following single and repeat inhalations
Timeframe: Day 1 of session 2 and day 10 of session 2
Ratio of accumulation factor (R[Cmax]) of GSK2269557 following single and repeat inhalations
Timeframe: Day 1 of session 2 and day 10 of session 2
Ratio of accumulation factor (R[Ctrough]) of GSK2269557 following single and repeat inhalations
Timeframe: Day 1 of session 2 and day 10 of session 2
Participation criteria
- Inclusion Criteria
- Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent.
- Inclusion Criteria
- Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Normal spirometry (forced expiratory volume in 1 second >=80% of predicted) at Screening.
- Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18.5 to 24.9 kg/square meter (m^2) (inclusive).
- Japanese Male: A male participant must agree to use contraception of this protocol during the treatment period and until follow up visit.
- Capable of giving signed informed consent as described in restrictions listed in the informed consent form (ICF). 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 treatment; or interfering with the interpretation of data
- Abnormal blood pressure as determined by the investigator
- ALT >1.5x upper limit of normal (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- 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).
- Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
- History of donation of blood or blood products >=400 milliliters (mL) within 3 months or >=200 mL within 1 month prior to screening
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
- Current enrollment or past participation within the last 30 days before signing of consent in this clinical study involving an investigational study treatment or any other type of medical research
- The subject is positive Serological test for syphilis (rapid plasma reagin and Treponema pallidum), Human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HbsAg), Hepatitis C virus (HCV) antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.
- Positive pre-study drug screen
- Regular use of known drugs of abuse
- Regular alcohol consumption within 6 months prior to the study defined as: for an average weekly intake of >14 units for males. One unit is equivalent to 350 ml of beer, 150 ml of wine or 45 ml of 80 proof distilled spirits
- Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.