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GSK2269557 ELLIPTA DPI

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Apr 26, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02972905Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2269557 to Japanese Healthy SubjectsPHASE1 COMPLETED 36 — — Oct 1, 2016Dec 1, 2016Jan 18, 20171 Japan
NCT02691325Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy SubjectsPHASE1 COMPLETED 22 — — Mar 14, 2016Jun 5, 2016Apr 26, 20171 United States
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Study Endpoints
Primary Endpoints
Number of subjects with any adverse event(s) (AE) and serious adverse event(s) (SAE)
Approximately up to 37 days

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

Session 1: Number of subjects having abnormal clinical laboratory parameters as a measure of safety
Approximately up to 4 days

Blood samples will be collected to analyse blood urea nitrogen, creatinine, glucose (fasting), uric acid, high density lipoprotein-cholesterol, amylase, potassium, sodium, calcium, triglycerides, lactate dehydrogenase (LDH), chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total cholesterol, gamma-glutamyl transpeptidase (GGT), phosphorus, total bilirubin, direct bilirubin, total protein, albumin, low density lipoprotein-cholesterol, creatine phosphokinase (CPK)

Session 2: Number of subjects having abnormal clinical laboratory parameters as a measure of safety
Approximately up to 22 days

Blood samples will be collected to analyse blood urea nitrogen, creatinine, glucose (fasting), uric acid, high density lipoprotein-cholesterol, amylase, potassium, sodium, calcium, triglycerides, LDH, chloride, AST, ALT, ALP, total cholesterol, GGT, phosphorus, total bilirubin, direct bilirubin, total protein, albumin, low density lipoprotein-cholesterol, CPK

Session 1:Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Approximately up to 4 days

Blood samples will be collected to analyse platelet count, Red Blood Cells (RBC) count, hemoglobin, hematocrit, RBC Indices, mean corpuscular volume ( MCV), mean corpuscular hemoglobin (MCH), percent reticulocytes, White Blood Cells (WBC), neutrophils, lymphocytes, monocytes, eosionophils, and basophils

Session 2: Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Approximately up to 22 days

Blood samples will be collected to analyse platelet count, RBC count, hemoglobin, hematocrit, RBC Indices, MCV, MCH, percent reticulocytes, WBC, neutrophils, lymphocytes, monocytes, eosionophils, and basophils

Session 1: Number of subjects having abnormal urinalysis as a measure of safety
Approximately up to 4 days

Urine samples will be collected to analyse specific gravity, pH, glucose, protein, blood, ketones, bilirubin, and urobilinogen for dipstick, and microscopic examination

Session 2: Number of subjects having abnormal urinalysis as a measure of safety
Approximately up to 22 days

Urine samples will be collected to analyse specific gravity, pH, glucose, protein, blood, ketones, bilirubin, and urobilinogen for dipstick, and microscopic examination

Session 1: Body temperature assessment as a safety measure
Approximately up to 4 days

Temperature will be recorded in a supine position after 5 minutes rest

Session 2: Body temperature assessment as a safety measure
Approximately up to 22 days

Temperature will be recorded in a supine position after 5 minutes rest

Session 1: Blood pressure assessment as a safety measure
Approximately up to 4 days

Systolic and diastolic blood pressure will be measured in a supine positon after 5 minutes rest

Session 2: Blood pressure assessment as a safety measure
Approximately up to 22 days

Systolic and diastolic blood pressure will be measured in a supine position after 5 minutes rest

Session 1: Measurement of pulse rate as a safety measure
Approximately up to 4 days

Pulse rate will be measured in a supine position after 5 minutes rest

Session 2: Measurement of pulse rate as a safety measure
Approximately up to 22 days

Pulse rate will be measured in a supine position after 5 minutes rest

Session 1: Electrocardiogram (ECG) assessment as a measure of safety.
Approximately up to 4 days

Single 12-lead ECG will be obtained in a supine position after 5 minutes rest using an ECG machine that measures PR, QRS, QT, and Corrected QT interval by Fridericia's formula (QTcF) intervals. Single ECGs will be obtained at each time point.

Session 2: ECG assessment as a measure of safety.
Approximately up to 22 days

Single 12-lead ECG will be obtained in a supine position after 5 minutes rest using an ECG machine that measures PR, QRS, QT, and QTcF intervals. Single ECGs will be obtained at each time point.

Session 1: Spirometry assessment as a safety measure
Approximately up to 4 days

Spirometry assessments will be performed whilst the subject is in a standing position. Assessments will be repeated until 3 technically acceptable measurements have been made.

Session 2: Spirometry assessment as a safety measure
Approximately up to 22 days

Spirometry assessments will be performed whilst the subject is in a standing position. Assessments will be repeated until 3 technically acceptable measurements have been made.

Session 1: Area under the plasma concentration curve (AUC) from time zero to the time of last quantifiable concentration [AUC(0-t)]
Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72hours (h) post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC \[0-t\]

Session 1: AUC from time zero to 24 hours post dose [AUC(0-24)] of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC\[0-24\]

Session 1: AUC from time zero to infinity [AUC(0-infinity)] of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC (0-infinity).

Session 2: AUC from time zero to the time of last quantifiable concentration [AUC(0-t)] of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC \[0-t\]

Session 2: AUC from time zero to 24 hours post dose [AUC(0-24)] of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC\[0-24\]

Session 2: AUC from time zero to infinity [AUC(0-infinity)] of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating AUC (0-infinity)

Session 1: Trough observed plasma drug concentration (Ctrough) of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Ctrough

Session 1: Maximum observed plasma concentration (Cmax) of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Cmax

Session 1: Maximum/trough observed plasma drug concentration (Cmax/Ctrough) of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 minutes (min), 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Cmax/Ctrough

Session 2: Trough observed plasma drug concentration (Ctrough) of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Ctrough

Session 2: Maximum observed plasma concentration (Cmax) of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Cmax

Session 2: Maximum/trough observed plasma drug concentration (Cmax/Ctrough) of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating Cmax/Ctrough

Session 1: Time to maximum observed plasma drug concentration (Tmax) of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating tmax

Session 1: Terminal half-life (t1/2) of GSK2269557 following a single dose administration
Pre-dose, 5, 15, 30 min, 1, 2 , 4 , 6, 12, 24, 36, 48, and 72h post-dose

Blood samples will be collected at pre-dose and at specific post dose time points for calculating t1/2

Session 2: Time to maximum observed plasma drug concentration (Tmax) of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating tmax

Session 2: Terminal half-life (t1/2) of GSK2269557 following repeat dose administration
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

Blood samples will be collected at pre-dose and at specific post dose time points for calculating tmax and t1/2

Ratio of accumulation factor (Ro) of GSK2269557 following single and repeat inhalations
Day 1 of session 2 and day 10 of session 2

Ro is defined as AUC(0-24) of Session 2 at day10 divided by AUC(0-24) of Session1

Ratio of accumulation factor (Rs) of GSK2269557 following single and repeat inhalations
Day 1 of session 2 and day 10 of session 2

Rs is defined as AUC(0-24) of Session 2 at day10 divided by AUC(0-infinity) of Session 1

Ratio of accumulation factor (R[Cmax]) of GSK2269557 following single and repeat inhalations
Day 1 of session 2 and day 10 of session 2

R\[Cmax\] is defined as Cmax of Session 2 at day10 divided by Cmax of Session 1

Ratio of accumulation factor (R[Ctrough]) of GSK2269557 following single and repeat inhalations
Day 1 of session 2 and day 10 of session 2

R\[Ctrough\] is defined as Ctrough of Session 2 at day10 divided by C24 of Session 1

Part A: Number of subjects with any adverse event(s) (AE) and serious adverse event(s) (SAE)
Up to 6 weeks

An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Part B and C: Number of subjects with any AE and SAE
Up to 4 weeks

An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Part A: Systolic and diastolic blood pressure as a measure of safety
Up to 9 weeks
Part B: Systolic and diastolic blood pressure as a measure of safety
Up to 7 weeks
Part C: Systolic and diastolic blood pressure as a measure of safety
Up to 8 weeks
Part A: Heart rate as a measure of safety
Up to 9 weeks
Part B: Heart rate as a measure of safety
Up to 7 weeks
Part C: Heart rate as a measure of safety
Up to 8 weeks
Part A: Temperature as a measure of safety
Up to 9 weeks
Part B: Temperature as a measure of safety
Up to 7 weeks
Part C: Temperature as a measure of safety
Up to 8 weeks
Part A: Respiratory rate as a measure of safety
Up to 9 weeks
Part B: Respiratory rate as a measure of safety
Up to 7 weeks
Part C: Respiratory rate as a measure of safety
Up to 8 weeks
Part A: 12-lead electrocardiogram (ECG) as a measure of safety
Up to 9 weeks

All scheduled ECGs will be performed after the subject has rested quietly for at least 5 minutes in a supine position.

Part B: 12-lead ECG as a measure of safety
Up to 7 weeks

All scheduled ECGs will be performed after the subject has rested quietly for at least 5 minutes in a supine position.

Part C: 12-lead ECG as a measure of safety
Up to 8 weeks
Part A: Composite of hematology parameters as a measure of safety
Up to 9 weeks

The following hematology parameters will be measured: hemoglobin, Hematocrit, Red blood cell (RBC) count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Platelet count, white blood cell (WBC) count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).

Part B: Composite of hematology parameters as a measure of safety
Up to 7 weeks

The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, MCV, MCH, Platelet count, WBC count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).

Part C: Composite of hematology parameters as a measure of safety
Up to 8 weeks

The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, MCV, MCH, Platelet count, WBC count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).

Part A: Composite of chemistry parameters as a measure of safety
Up to 9 weeks

The following chemistry parameters will be measured: Blood Urea nitrogen (BUN), Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total Bilirubin, Alkaline phosphatase (ALP), Total albumin, Total protein, Total bilirubin and Direct bilirubin.

Part B: Composite of chemistry parameters as a measure of safety
Up to 7 weeks

The following chemistry parameters will be measured: BUN, Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, AST, ALT, ALP, Total albumin, Total protein, Total bilirubin and Direct bilirubin.

Part C: Composite of chemistry parameters as a measure of safety
Up to 8 weeks

The following chemistry parameters will be measured: BUN, Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, AST, ALT, ALP, Total albumin, Total protein, Total bilirubin and Direct bilirubin.

Part A: Composite of urinalysis parameters as a measure of safety
Up to 6 weeks

The following urinalysis parameters will be measured: power of hydrogen (pH), Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)

Part B: Composite of urinalysis parameters as a measure of safety
Up to 4 weeks

The following urinalysis parameters will be measured: pH, Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)

Part C: Composite of urinalysis parameters as a measure of safety
Up to 4 weeks

The following urinalysis parameters will be measured: pH, Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)

Part A, B and C: Spirometry measurement as a measure of safety
Screening and Day 1 (Pre-dose and 30 minute (min) post-dose)
Secondary Endpoints
Part A and C: Plasma concentrations of GSK2269557
Pre-dose, 5 min and 30 min, 1 hour (h), 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
Part B: Plasma concentrations of GSK2269557
Day 1: pre-dose, and 5 minute (min) and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
Part A and C: Area under the plasma concentration curve (AUC) from time zero to infinity [AUC(0-infinity)] of GSK2269557 following single dose administration
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Session 1: PlaceboPLACEBO_COMPARATORSubjects will receive a single dose inhalation of GSK2269557 matching placebo via the ELLIPTA DPI. The washout period between the two dosing sessions will be at least 10 days.
Session 1: GSK2269557 200 mcgEXPERIMENTALSubjects will receive a single dose inhalation of GSK2269557 200 mcg via the ELLIPTA DPI. The washout period between the two dosing sessions will be at least 10 days.
Session 1: GSK2269557 500 mcgEXPERIMENTALSubjects will receive a single dose inhalation of GSK2269557 500 mcg via the ELLIPTA DPI. The washout period between the two dosing sessions will be at least 10 days.
Session 1: GSK2269557 700 mcgEXPERIMENTALSubjects will receive a single dose inhalation of GSK2269557 700 mcg via the ELLIPTA DPI. The washout period between the two dosing sessions will be at least 10 days.
Session 2: PlaceboPLACEBO_COMPARATORSubjects will receive repeated doses of GSK2269557 matching Placebo once daily via the ELLIPTA DPI for 10 days. The washout period between the two dosing sessions will be at least 10 days.
Session 2: GSK2269557 200 mcgEXPERIMENTALSubjects will receive repeated doses of GSK2269577 200mcg once daily via the ELLIPTA DPI for 10 days. The washout period between the two dosing sessions will be at least 10 days.
Session 2: GSK2269557 500 mcgEXPERIMENTALSubjects will receive repeated doses of GSK2269577 500mcg once daily via the ELLIPTA DPI for 10 days. The washout period between the two dosing sessions will be at least 10 days.
Session 2: GSK2269557 700 mcgEXPERIMENTALSubjects will receive repeated doses of GSK2269577 700mcg once daily via the ELLIPTA DPI for 10 days. The washout period between the two dosing sessions will be at least 10 days.
Part A (Sequence 1) - Placebo, GSK2269557 200 mcgEXPERIMENTALSubjects will receive a single dose of GSK2269557 matching placebo (one inhalation) in treatment period 1, and single dose of GSK2269557 200 microgram (mcg) (2 inhalations of GSK2269557 100 mcg) in treatment period 2 via the ELLIPTA DPI. The washout period between each dosing day will be at least 14 days. Doses of GSK2269557 may be modified based on emerging data.
Part A (Sequence 2) - GSK2269557 100 mcg, PlaceboEXPERIMENTALSubjects will receive a single dose of GSK2269557 100 mcg (one inhalation) in treatment period 1, and single dose of GSK2269557 matching placebo (two inhalations) in treatment period 2 via the ELLIPTA DPI. The washout period between each dosing day will be at least 14 days. Doses of GSK2269557 may be modified based on emerging data.
Part A (Sequence 3) - GSK2269557 100 mcg, GSK2269557 200 mcgEXPERIMENTALSubjects will receive a single dose of GSK2269557 100 mcg (one inhalation) in treatment period 1, and single dose of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) in treatment period 2 via the ELLIPTA DPI. The washout period between each dosing day will be at least 14 days. Doses of GSK2269557 may be modified based on emerging data.
Part B- GSK2269557 200 mcgEXPERIMENTALSubjects will receive repeated doses of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) once daily via the ELLIPTA DPI for 10 days. Doses of GSK2269557 may be modified based on emerging data from Part A.
Part B- GSK2269557 matching PlaceboEXPERIMENTALSubjects will receive repeated doses of GSK2269557 matching Placebo (2 inhalations) once daily via the ELLIPTA DPI for 10 days.
Part C- GSK2269557 200 mcg with and without activated charcoalEXPERIMENTALSubjects will receive a single dose of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) via the ELLIPTA DPI with activated charcoal in one treatment period and without ingestion of activated charcoal in another treatment period. The washout period between each dosing day will be at least 14 days. Dose of GSK2269557 may be modified based on emerging data from Part A.
Interventions
NameTypeDescription
GSK2269557 ELLIPTA DPIDRUGGSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate. This will be supplied in two strength of 100 mcg per blister and 500 mcg per blister.
Placebo ELLIPTA DPIDRUGPlacebo ELLIPTA DPI contains lactose
Activated charcoalDRUGThe activated charcoal will be supplied by the clinical site. Charcoal will be administered as a suspension of 5 gram activated charcoal in 40 mL of water. The suspension will be made to drunk, in its entirety.
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Eligibility Criteria
Age Range20 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 abn...

Countries:JapanUnited States
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