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A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses

A Three Part, Non-randomized, Open Label Study Designed to Assess the Pharmacokinetics of GSK2982772 Following Administration of Minitab Modified Release Formulations in a Capsule Relative to an Immediate Release Reference Tablet Formulation (Part A), the Pharmacokinetics of Escalating, Repeat Doses of a Selected Minitab Modified Release Prototype (Part B) , and the Pharmacokinetics of GSK2982772 Following Administration of Modified Release Tablet Formulations in the Fed and Fasted State (Part C) in Healthy Participants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03266172
Enrollment
45
Registered
2017-08-30
Start date
2017-09-27
Completion date
2018-11-21
Last updated
2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases

Keywords

immediate release tablet, GSK2982772, Modified release, minitablet

Brief summary

GSK2982772 is a first-in-class, highly selective, receptor-interacting protein-1 (RIP1) kinase inhibitor being developed for the treatment of inflammatory bowel disease, plaque psoriasis (PsO), rheumatoid arthritis (RA) and other disease conditions. PK data from the first time in human (FTIH) study for GSK2982772 showed that the half life of GSK2982772 was short (approximately 2 to 3 hours). A once daily (QD) formulation would be more convenient from a subject perspective and could offer the advantage of providing a flatter GSK2982772 concentration time profile. Following completion of Parts A and B, it was determined that the slowest minitab formulation provided a PK profile suitable for QD dosing but this formulation was susceptible to a food effect. This study will evaluate the pharmacokinetics of GSK2982772 following administration of different minitab MR formulations in a capsule relative to an IR reference tablet formulation, the pharmacokinetics of selected MR formulation in capsule following repeat doses for 3 days and to compare the pharmacokinetics of GSK2982772 following administration of MR tablet formulations in the fed and fasted state relative to an IR tablet formulation. The study is divided into three parts: Part A will be a non-randomized 6 periods, sequential, 6-way fixed sequence design in which up to 4 MR minitab formulations in a capsule will be evaluated. Periods 1, 2, and 3 will evaluate a slow MR release duration (nominally 24 hours), a fast MR release duration (nominally 10 hours), and IR tablet respectively. Periods 4, 5 and 6 will have flexible dose regimen and it will depend on the outcomes of Period 1 to 3. Subjects will be admitted to the clinic the previous day before dosing. Each in-patient period will consist of 3 days and 2 nights followed by a minimum washout period of 7 days between doses, for both Part A and C. In Part A and C, 16 healthy subjects will be enrolled such that at least 12 evaluable subjects complete the study. Part B will be an open-label, repeat dose study in which the selected MR minitab formulation in capsule will be evaluated. Each in-patient period will consist of 5 days and 4 nights. There will be a minimum of 7 days washout period between the last morning dose of one period and the first dose of the next period. In Part B, 10 healthy subjects will be enrolled such that at least 6 evaluable subjects complete the study. Part C of the study will be a non-randomised 6 period, sequential, fixed sequence crossover design in which MR tablet formulations will be evaluated. Periods 1 and 2 will evaluate single dose administration of a 240 milligram (mg) MR tablet and the 240 mg IR tablet (reference), respectively. Periods 3, 4, 5 and 6 will be flexible and the dosing regimen will be dependent on the outcome of Periods 1 and 2.

Interventions

GSK2982772 MR will be available as prototype MR minitablet in capsules with unit dose strength of 60 mg in Part A. In Part B, GSK2982772 MR minitablet in capsules with unit dose strength of 15, 30 or 60 mg will be administered by subjects for Days 1 to 3. In Part C, GSK2982772 MR tablet with unit dose strength of 240, 360 or 480 mg will be administered by subjects. GSK2982772 MR will be administered orally with 240 mL of water.

In part A, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 120 mg (4 tablets of dose strength 30 mg) orally with 240 mL of water. In part C, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 240 mg (8 tablets of dose strength 30 mg) orally with 240 mL of water.

Sponsors

Quotient Clinical
CollaboratorOTHER
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Part A of the study will be a non-randomized 6 period, sequential, 6-way fixed sequence design. Part B of the study will be a repeat dose study. Part C of the study will be a non-randomized 6 period, sequential, fixed sequence crossover design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body weight greater than and equal to 50 kilogram (kg) and body mass index within the range 19.0 to 32.0 kilogram per meter square (kg/m\^2) (inclusive). * A male subject must agree to use a highly effective contraception during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive during the treatment period and for at least 30 days before and 30 days after the last dose of study treatment. * Capable of giving signed informed consent.

Exclusion criteria

* History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), 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. * Parts A and C only: Any history of suicidal behavior within the past 6 months or any history of attempted suicide in a subject's lifetime. * Part B only: Subjects with current history of suicidal ideation behavior as measured using the columbia-suicide severity rating scale (C-SSRS) or a history of attempted suicide. * History of clinically significant psychiatric disorders as judged by the investigator. Depression requiring treatment in the last 2 years. * History of herpes zoster (shingles) reactivation. * History or diagnosis of obstructive sleep apnea. * History of a significant respiratory disorder. Childhood asthma that has fully resolved is permitted. * History or current evidence of febrile seizures, epilepsy, convulsions, significant head injury, or other significant neurologic conditions. * A positive diagnostic tuberculosis (TB) test at screening defined as a positive QuantiFERON-TB Gold test or T-spot test. In cases where the QuantiFERON or T spot test is indeterminate, the subject may have the test repeated once, but they will not be eligible for the study unless the second test is negative. * History of GI surgery (with exception of appendectomy). * History of cholecystectomy or gall stones. * Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. * ALT greater than 1.5 times upper limit of normal (ULN). * Bilirubin greater than 1.5 times ULN (isolated bilirubin greater than 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percentage of total). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome). * Corrected QT interval (QTc) greater than 450 millisecond (msec). * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 gram (g) per day\], hormone replacement therapy and hormonal contraception are permitted). * Live or attenuated vaccine(s) within 30 days of enrolment, or plans to receive such vaccines during the study or plans to receive a vaccine within 30 days + 5 half-lives of the last dose of study medication. * Subject in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within a 56 day period; therefore donation or loss of greater than 400 mL of blood within the previous 3 months. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation within the last 3 months before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research. * Subjects who have previously been enrolled in this study. Subjects in Part A of this study are not permitted to participate in Part B. Subjects in Parts A or B of this study are not permitted to participate in Part C. * Current or history of renal disease or estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation calculation less than 60 mL/minutes(min)/1.73m\^2 at screening. * Presence of Hepatitis B surface antigen (HBsAg) at screening Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose. As potential for and magnitude of immunosuppression with this compound is unknown, subjects with presence of hepatitis B core antibody (HBcAb) should be excluded. Subjects positive for HBsAg and/or positive for anti-HBc antibody (regardless of anti-HBs antibody status) are excluded. * An elevated C-reactive protein (CRP) outside the normal reference range. * Part B only: A positive anti-nuclear antibody (ANA) outside the normal reference range. * Confirmed positive pre-study drug/alcohol screen. * Positive human immunodeficiency virus (HIV) antibody test. * Regular use of known drugs of abuse, or history of drug or alcohol abuse in the past 5 years. * Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for 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 use or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening. A carbon monoxide breath test reading of greater than 10 parts per million (ppm). * 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. * Unwilling or unable to swallow multiple size 0-00 capsules as part of study participation. * Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening. * Total cholesterol greater than or equal to 300 milligram/deciliter (mg/dL) (greater than or equal to 7.77 millimoles per liter \[mmol\]/L\]) or triglycerides greater than or equal to 250 mg/dL (greater than or equal to 2.82 mmol/L). * Subjects who are study site employees, or immediate family members of a study site or sponsor employee.

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Participants in the 'Safety Population' for whom a Pharmacokinetic (PK) sample was obtained and analyzed were part of PK Population.
AUC(0-inf) of GSK2982772 in MT Formulation :Part APre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-inf).
Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-t)
AUC(0-t) of GSK2982772 in MT Formulation: Part APre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-t)
Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-24)
AUC(0-24) of GSK2982772 in MT Formulation: Part APre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-24)
Area Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-12)
AUC(0-12) of GSK2982772 in MT Formulation: Part APre-dose, 2, 4, 6, 8, 10, and 12 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for AUC (0-12)
Maximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for Cmax
Cmax of GSK2982772 in MT Formulation: Part APre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for Cmax
Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A12 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for C12hour.
Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A24 hours post-doseBlood samples were collected from participants at indicated time points and analyzed for C24hour.
Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose (test)Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT (test) / Geometric mean of AUC (0-inf) of IR Formulation (reference) multiplied by 100.
Frelformulation Based on AUC (0-24) of GSK2982772 in Part APre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose (test)Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MT (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.
Frelformulation Based on Cmax of GSK2982772 in Part APre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose(test)Blood samples were collected at indicated time points for analysis of Frelformulation. Frel was calculated as Geometric mean of Cmax of MT Formulation (test)/ Geometric mean of Cmax of IR Formulation (reference) multiplied by 100.
Ratio of Cmax to C12hour of GSK2982772 in IR Formulation: Part APre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.
Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part APre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.
Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part APre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.
Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part APre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.
Time to Cmax (Tmax) of GSK2982772 in IR Formulation: Part APre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-doseBlood samples were collected at indicated time points for analysis of Tmax.
Tmax of GSK2982772 in MT Formulation: Part APre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Tmax.
AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-inf)
AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-inf).
AUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-t).
AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-t).
AUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-24)
AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-24)
AUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-12)
AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, and 12 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-12)
Cmax of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of Cmax
Cmax of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Cmax
C12 of GSK2982772 in Part C: Fasted State12 hours post-doseBlood samples was collected at indicated time point for analysis of C12
C24 of GSK2982772 in Part C: Fasted State24 hours post-doseBlood samples was collected at indicated time point for analysis of C24
Ratio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.
Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.
Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted StatePre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.
Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted StatePre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.
Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose(test)Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MM formulation (test) / Geometric mean of AUC (0-t) of IR Formulation (reference) multiplied by 100.
Frelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted StatePre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose(test)Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MM Fasted formulation (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.

Secondary

MeasureTime frameDescription
Change From Baseline in Respiration Rate: Part CBaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursRespiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part APre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after a high fat meal. Frel for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT Fed formulation (test) / Geometric mean of AUC (0-inf) of MT Fasted Formulation (reference) multiplied by 100.
Change From Baseline in Body Temperature: Part CBaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursBody temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part APre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772 after a high fat meal. Frel for Cmax was calculated as Geometric mean of Cmax of MT Fed formulation (test) / Geometric mean of Cmax of MT Fasted Formulation (reference) multiplied by 100.
AUC(0-24) of GSK2982772 in Part BPre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Blood samples were collected at indicated time points for analysis of AUC (0-24)
Cmax of GSK2982772 in Part BPre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Blood samples were collected at indicated time points for analysis of Cmax
Tmax of GSK2982772 in Part BPre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Blood samples were collected at indicated time points for analysis of Tmax
AUC (0-24) of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-24)
Cmax of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hoursBlood samples were collected at indicated time points for analysis of Cmax
C12 of GSK2982772 After Meal in Part C12 hours post-doseBlood samples were collected at indicated time points for analysis of C12
AUC(0-t) of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-t)
AUC(0-inf) of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-inf) after meal.
AUC(0-12) of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, and 12 hours post-doseBlood samples were collected at indicated time points for analysis of AUC (0-12) after meal.
Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after meal. Frel for Auc (0-t) was calculated as Geometric mean of AUC (0-t) of MM Fed formulation (fed) / Geometric mean of AUC (0-t) of MM Fasted Formulation (fasted) multiplied by 100.
Frelformulation Based on Cmax of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 after meal. Frel for Cmax was calculated as Geometric mean of Cmax of MM Fed formulation (test) / Geometric mean of Cmax of MM Fasted Formulation (reference) multiplied by 100.
Tmax of GSK2982772 After Meal in Part CPre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-doseBlood samples were collected at indicated time points for analysis of Tmax of GSK2982772 after meal.
Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AUp to Day 43An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before. All participants who receive at least 1 dose of study treatment and were included in Safety Population. Participants will be analyzed according to the treatment they actually received.
Number of Participants With AE and SAE in Part BUp to Day 22An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Number of Participants With AE and SAE in Part CUp to Day 43An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AUp to Day 43Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants Abnormal Urinalysis Dipstick Results: Part BUp to Day 22Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AUp to Day 43Blood samples were collected to analyze hematology parameters like platelet count, white blood cell (WBC) count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants Abnormal Urinalysis Dipstick Results: Part AUp to Day 43Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BUp to Day 22Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BUp to Day 22Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CUp to Day 43Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CUp to Day 43Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants Abnormal Urinalysis Dipstick Results: Part CUp to Day 43Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part AUp to Day 43Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and Corrected QT (QTc) intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants Abnormal ECG Findings: Part BUp to Day 22Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Number of Participants Abnormal ECG Findings: Part CUp to Day 43Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Change From Baseline in Blood Pressure: Part ABaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursSystolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Heart Rate: Part ABaseline (Day 1 Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursHeart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Respiration Rate: Part ABaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursRespiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value
Change From Baseline in Body Temperature: Part ABaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursBody temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Blood Pressure: Part BBaseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursSBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Heart Rate: Part BBaseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursHeart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Respiration Rate: Part BBaseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4 24 hoursRespiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value
Change From Baseline in Body Temperature: Part BBaseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursBody temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Blood Pressure: Part CBaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursSBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Change From Baseline in Heart Rate: Part CBaseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursHeart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Countries

United Kingdom

Participant flow

Recruitment details

This was an open label, 3-part, single and repeat dose study conducted in healthy participants to assess modified release (MR) minitablets (MT) in a capsule and MR monolithic matrix (MM) formulations of GSK2982772 compared to immediate release (IR) tablet formulation of GSK2982772.

Pre-assignment details

In this study, total 45 participants were enrolled.

Participants by arm

ArmCount
MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)
Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
19
MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)
Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
10
MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF
Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed \[DF\]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (delayed fed). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
16
Total45

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Part A: Period 1(2 Days)Withdrawal by Subject100
Part A: Washout Period (7 Days)Adverse Event100
Part A: Washout Period (7 Days)Withdrawal by Subject100
Part B: Washout (7 Days)Withdrawal by Subject020
Part C Washout Period (7 Days)Withdrawal by Subject001

Baseline characteristics

CharacteristicMT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DFTotal
Age, Continuous49.2 Years
STANDARD_DEVIATION 14.1
47.8 Years
STANDARD_DEVIATION 13.43
45.3 Years
STANDARD_DEVIATION 12.22
47.5 Years
STANDARD_DEVIATION 13.12
Race/Ethnicity, Customized
Asian - East Asian Heritage
1 Participants0 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Asian - South East Asian Heritage
0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
18 Participants10 Participants14 Participants42 Participants
Sex: Female, Male
Female
8 Participants4 Participants7 Participants19 Participants
Sex: Female, Male
Male
11 Participants6 Participants9 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
deaths
Total, all-cause mortality
0 / 161 / 160 / 130 / 160 / 100 / 100 / 60 / 150 / 150 / 160 / 160 / 150 / 14
other
Total, other adverse events
4 / 165 / 161 / 132 / 161 / 103 / 101 / 63 / 153 / 153 / 164 / 162 / 151 / 14
serious
Total, serious adverse events
0 / 161 / 160 / 130 / 160 / 100 / 100 / 60 / 150 / 150 / 160 / 160 / 150 / 14

Outcome results

Primary

Area Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedArea Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part A5.967 Hours*microgram per milliliterGeometric Coefficient of Variation 38.4
Primary

Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedArea Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part A6.256 Hours*microgram per milliliterGeometric Coefficient of Variation 39.2
Primary

Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Participants in the 'Safety Population' for whom a Pharmacokinetic (PK) sample was obtained and analyzed were part of PK Population.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedArea Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A6.305 Hours*microgram per milliliterGeometric Coefficient of Variation 39.4
Primary

Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedArea Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part A6.258 Hours*microgram per milliliterGeometric Coefficient of Variation 39.2
Primary

AUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-12)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted State13.500 Hours*microgram per milliliterGeometric Coefficient of Variation 26.3
Primary

AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-12)

Time frame: Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State6.096 Hours*microgram per milliliterGeometric Coefficient of Variation 32.8
Part A: MT-8hour 120mg FastedAUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State12.508 Hours*microgram per milliliterGeometric Coefficient of Variation 40.1
Primary

AUC(0-12) of GSK2982772 in MT Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)

Time frame: Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-12) of GSK2982772 in MT Formulation: Part A2.106 Hours*microgram per milliliterGeometric Coefficient of Variation 45.1
Part A: MT-8hour 120mg FastedAUC(0-12) of GSK2982772 in MT Formulation: Part A3.066 Hours*microgram per milliliterGeometric Coefficient of Variation 47.7
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-12) of GSK2982772 in MT Formulation: Part A3.573 Hours*microgram per milliliterGeometric Coefficient of Variation 40.8
Primary

AUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-24)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted State14.619 Hours*microgram per milliliterGeometric Coefficient of Variation 25.7
Primary

AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-24)

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State8.769 Hours*microgram per milliliterGeometric Coefficient of Variation 30.9
Part A: MT-8hour 120mg FastedAUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State18.177 Hours*microgram per milliliterGeometric Coefficient of Variation 31.5
Primary

AUC(0-24) of GSK2982772 in MT Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at specified time frame were analyzed

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-24) of GSK2982772 in MT Formulation: Part A3.558 Hours*microgram per milliliterGeometric Coefficient of Variation 43.6
Part A: MT-8hour 120mg FastedAUC(0-24) of GSK2982772 in MT Formulation: Part A4.255 Hours*microgram per milliliterGeometric Coefficient of Variation 49.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-24) of GSK2982772 in MT Formulation: Part A4.580 Hours*microgram per milliliterGeometric Coefficient of Variation 39.5
Primary

AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-inf)

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population. Only those participants with data available at specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State14.797 Hours*microgram per milliliterGeometric Coefficient of Variation 26.3
Primary

AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-inf).

Time frame: Pre-dose, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State13.417 Hours*microgram per milliliterGeometric Coefficient of Variation 23.4
Part A: MT-8hour 120mg FastedAUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State22.493 Hours*microgram per milliliterGeometric Coefficient of Variation 51.3
Primary

AUC(0-inf) of GSK2982772 in MT Formulation :Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf).

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-inf) of GSK2982772 in MT Formulation :Part A3.852 Hours*microgram per milliliterGeometric Coefficient of Variation 39.4
Part A: MT-8hour 120mg FastedAUC(0-inf) of GSK2982772 in MT Formulation :Part A4.482 Hours*microgram per milliliterGeometric Coefficient of Variation 47.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-inf) of GSK2982772 in MT Formulation :Part A5.314 Hours*microgram per milliliterGeometric Coefficient of Variation 39.7
Primary

AUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-t).

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted State14.621 Hours*microgram per milliliterGeometric Coefficient of Variation 25.7
Primary

AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of AUC (0-t).

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State9.676 Hours*microgram per milliliterGeometric Coefficient of Variation 29.6
Part A: MT-8hour 120mg FastedAUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State20.009 Hours*microgram per milliliterGeometric Coefficient of Variation 29.7
Primary

AUC(0-t) of GSK2982772 in MT Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-t) of GSK2982772 in MT Formulation: Part A3.805 Hours*microgram per milliliterGeometric Coefficient of Variation 42.3
Part A: MT-8hour 120mg FastedAUC(0-t) of GSK2982772 in MT Formulation: Part A4.449 Hours*microgram per milliliterGeometric Coefficient of Variation 49.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-t) of GSK2982772 in MT Formulation: Part A4.720 Hours*microgram per milliliterGeometric Coefficient of Variation 38.4
Primary

C12 of GSK2982772 in Part C: Fasted State

Blood samples was collected at indicated time point for analysis of C12

Time frame: 12 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedC12 of GSK2982772 in Part C: Fasted State0.197 Microgram per milliliterGeometric Coefficient of Variation 62.9
Part A: MT-8hour 120mg FastedC12 of GSK2982772 in Part C: Fasted State0.346 Microgram per milliliterGeometric Coefficient of Variation 41.7
Part A: MT-12hour 120mg Fed (High Fat)C12 of GSK2982772 in Part C: Fasted State0.671 Microgram per milliliterGeometric Coefficient of Variation 42.3
Primary

C24 of GSK2982772 in Part C: Fasted State

Blood samples was collected at indicated time point for analysis of C24

Time frame: 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedC24 of GSK2982772 in Part C: Fasted State0.025 Microgram per milliliterGeometric Coefficient of Variation 54.9
Part A: MT-8hour 120mg FastedC24 of GSK2982772 in Part C: Fasted State0.162 Microgram per milliliterGeometric Coefficient of Variation 52.6
Part A: MT-12hour 120mg Fed (High Fat)C24 of GSK2982772 in Part C: Fasted State0.351 Microgram per milliliterGeometric Coefficient of Variation 52.5
Primary

Cmax of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of Cmax

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedCmax of GSK2982772 for IR Formulation in Part C: Fasted State2.938 Microgram per milliliterGeometric Coefficient of Variation 25.2
Primary

Cmax of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of Cmax

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedCmax of GSK2982772 for MM Formulation in Part C: Fasted State0.918 Microgram per milliliterGeometric Coefficient of Variation 34.2
Part A: MT-8hour 120mg FastedCmax of GSK2982772 for MM Formulation in Part C: Fasted State2.010 Microgram per milliliterGeometric Coefficient of Variation 50.1
Primary

Cmax of GSK2982772 in MT Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for Cmax

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedCmax of GSK2982772 in MT Formulation: Part A0.277 Microgram per milliliterGeometric Coefficient of Variation 58.8
Part A: MT-8hour 120mg FastedCmax of GSK2982772 in MT Formulation: Part A0.439 Microgram per milliliterGeometric Coefficient of Variation 54.9
Part A: MT-12hour 120mg Fed (High Fat)Cmax of GSK2982772 in MT Formulation: Part A0.624 Microgram per milliliterGeometric Coefficient of Variation 49.4
Primary

Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A

Blood samples were collected from participants at indicated time points and analyzed for C12hour.

Time frame: 12 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedConcentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A0.220 Microgram per milliliterGeometric Coefficient of Variation 52.6
Part A: MT-8hour 120mg FastedConcentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A0.209 Microgram per milliliterGeometric Coefficient of Variation 56.2
Part A: MT-12hour 120mg Fed (High Fat)Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A0.208 Microgram per milliliterGeometric Coefficient of Variation 53.1
Part A: IR 120mg FastedConcentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A0.045 Microgram per milliliterGeometric Coefficient of Variation 81.7
Primary

Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A

Blood samples were collected from participants at indicated time points and analyzed for C24hour.

Time frame: 24 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedConcentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A0.058 Microgram per milliliterGeometric Coefficient of Variation 73.2
Part A: MT-8hour 120mg FastedConcentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A0.046 Microgram per milliliterGeometric Coefficient of Variation 69.5
Part A: MT-12hour 120mg Fed (High Fat)Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A0.030 Microgram per milliliterGeometric Coefficient of Variation 46.6
Part A: IR 120mg FastedConcentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A0.006 Microgram per milliliterGeometric Coefficient of Variation 108.8
Primary

Frelformulation Based on AUC (0-24) of GSK2982772 in Part A

Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MT (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose (test)

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on AUC (0-24) of GSK2982772 in Part A68.18 Percentage bioavailability
Part A: MT-8hour 120mg FastedFrelformulation Based on AUC (0-24) of GSK2982772 in Part A57.54 Percentage bioavailability
Primary

Frelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MM Fasted formulation (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose(test)

Population: PK Population. Only those participants with data available at the specified data points were analyzed

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted State59.98 Percentage bioavailability
Primary

Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MM formulation (test) / Geometric mean of AUC (0-t) of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose(test)

Population: PK Population.

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State66.18 Percentage bioavailability
Primary

Frelformulation Based on Cmax of GSK2982772 in Part A

Blood samples were collected at indicated time points for analysis of Frelformulation. Frel was calculated as Geometric mean of Cmax of MT Formulation (test)/ Geometric mean of Cmax of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose(test)

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on Cmax of GSK2982772 in Part A32.13 Percentage bioavailability
Part A: MT-8hour 120mg FastedFrelformulation Based on Cmax of GSK2982772 in Part A20.39 Percentage bioavailability
Primary

Maximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part A

Blood samples were collected from participants at indicated time points and analyzed for Cmax

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedMaximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part A1.375 Microgram per milliliterGeometric Coefficient of Variation 40.1
Primary

Ratio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted State17.158 RatioStandard Deviation 7.9158
Primary

Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State2.892 RatioStandard Deviation 1.2572
Part A: MT-8hour 120mg FastedRatio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State3.551 RatioStandard Deviation 2.2615
Primary

Ratio of Cmax to C12hour of GSK2982772 in IR Formulation: Part A

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C12hour of GSK2982772 in IR Formulation: Part A36.485 RatioStandard Deviation 20.9265
Primary

Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A1.284 RatioStandard Deviation 0.2468
Part A: MT-8hour 120mg FastedRatio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A2.265 RatioStandard Deviation 0.9119
Part A: MT-12hour 120mg Fed (High Fat)Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A3.240 RatioStandard Deviation 1.225
Primary

Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.

Time frame: Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Population: PK Population.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State138.239 RatioStandard Deviation 76.3996
Primary

Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State6.026 RatioStandard Deviation 2.1936
Part A: MT-8hour 120mg FastedRatio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State7.991 RatioStandard Deviation 10.6319
Primary

Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.

Time frame: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A312.851 RatioStandard Deviation 221.764
Primary

Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A

Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (MEAN)Dispersion
Part A: IR 120mg FastedRatio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A6.119 RatioStandard Deviation 5.1507
Part A: MT-8hour 120mg FastedRatio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A10.790 RatioStandard Deviation 4.9019
Part A: MT-12hour 120mg Fed (High Fat)Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A22.915 RatioStandard Deviation 11.7978
Primary

Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A

Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT (test) / Geometric mean of AUC (0-inf) of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose (test)

Population: PK Population. Only those participants with data available at specified time frame were analyzed.

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedRelative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A72.77 Percentage bioavailability
Part A: MT-8hour 120mg FastedRelative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A60.53 Percentage bioavailability
Primary

Time to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A

Blood samples were collected at indicated time points for analysis of Tmax.

Time frame: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population

ArmMeasureValue (MEDIAN)
Part A: IR 120mg FastedTime to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A2.000 Hours
Primary

Tmax of GSK2982772 in MT Formulation: Part A

Blood samples were collected at indicated time points for analysis of Tmax.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (MEDIAN)
Part A: IR 120mg FastedTmax of GSK2982772 in MT Formulation: Part A10.000 Hours
Part A: MT-8hour 120mg FastedTmax of GSK2982772 in MT Formulation: Part A4.000 Hours
Part A: MT-12hour 120mg Fed (High Fat)Tmax of GSK2982772 in MT Formulation: Part A6.000 Hours
Secondary

AUC(0-12) of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of AUC (0-12) after meal.

Time frame: Pre-dose and at 2, 4, 6, 8, 10, and 12 hours post-dose

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-12) of GSK2982772 After Meal in Part C17.111 Hours*microgram/milliliterGeometric Coefficient of Variation 45
Part A: MT-8hour 120mg FastedAUC(0-12) of GSK2982772 After Meal in Part C10.241 Hours*microgram/milliliterGeometric Coefficient of Variation 45.9
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-12) of GSK2982772 After Meal in Part C6.771 Hours*microgram/milliliterGeometric Coefficient of Variation 56.7
Secondary

AUC (0-24) of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of AUC (0-24)

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose

Population: PK Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC (0-24) of GSK2982772 After Meal in Part C17.505 Hours*microgram/milliliterGeometric Coefficient of Variation 29.5
Part A: MT-8hour 120mg FastedAUC (0-24) of GSK2982772 After Meal in Part C8.734 Hours*microgram/milliliterGeometric Coefficient of Variation 47.4
Part A: MT-12hour 120mg Fed (High Fat)AUC (0-24) of GSK2982772 After Meal in Part C21.543 Hours*microgram/milliliterGeometric Coefficient of Variation 39.2
Secondary

AUC(0-24) of GSK2982772 in Part B

Blood samples were collected at indicated time points for analysis of AUC (0-24)

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3

Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-24) of GSK2982772 in Part BDay 1, n=10, 9, 54.669 Hours*microgram/milliliterGeometric Coefficient of Variation 26.5
Part A: IR 120mg FastedAUC(0-24) of GSK2982772 in Part BDay 3, n=10, 10, 65.010 Hours*microgram/milliliterGeometric Coefficient of Variation 32
Part A: MT-8hour 120mg FastedAUC(0-24) of GSK2982772 in Part BDay 1, n=10, 9, 58.807 Hours*microgram/milliliterGeometric Coefficient of Variation 34.3
Part A: MT-8hour 120mg FastedAUC(0-24) of GSK2982772 in Part BDay 3, n=10, 10, 69.867 Hours*microgram/milliliterGeometric Coefficient of Variation 30.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-24) of GSK2982772 in Part BDay 1, n=10, 9, 59.662 Hours*microgram/milliliterGeometric Coefficient of Variation 33.8
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-24) of GSK2982772 in Part BDay 3, n=10, 10, 610.948 Hours*microgram/milliliterGeometric Coefficient of Variation 37.7
Secondary

AUC(0-inf) of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of AUC (0-inf) after meal.

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-inf) of GSK2982772 After Meal in Part C18.941 Hours*microgram/milliliterGeometric Coefficient of Variation 36.5
Part A: MT-8hour 120mg FastedAUC(0-inf) of GSK2982772 After Meal in Part C9.995 Hours*microgram/milliliterGeometric Coefficient of Variation 62.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-inf) of GSK2982772 After Meal in Part C24.367 Hours*microgram/milliliterGeometric Coefficient of Variation 49.2
Secondary

AUC(0-t) of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of AUC (0-t)

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedAUC(0-t) of GSK2982772 After Meal in Part C19.147 Hours*microgram/milliliterGeometric Coefficient of Variation 28
Part A: MT-8hour 120mg FastedAUC(0-t) of GSK2982772 After Meal in Part C9.202 Hours*microgram/milliliterGeometric Coefficient of Variation 46.4
Part A: MT-12hour 120mg Fed (High Fat)AUC(0-t) of GSK2982772 After Meal in Part C22.712 Hours*microgram/milliliterGeometric Coefficient of Variation 36.2
Secondary

C12 of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of C12

Time frame: 12 hours post-dose

Population: PK Population. Only participants with data available at the specified time points were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedC12 of GSK2982772 After Meal in Part C0.706 Microgram/milliliterGeometric Coefficient of Variation 72.7
Part A: MT-8hour 120mg FastedC12 of GSK2982772 After Meal in Part C0.739 Microgram/milliliterGeometric Coefficient of Variation 37.1
Part A: MT-12hour 120mg Fed (High Fat)C12 of GSK2982772 After Meal in Part C0.317 Microgram/milliliterGeometric Coefficient of Variation 49.5
Secondary

Change From Baseline in Blood Pressure: Part A

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 1, 12 hours, n=16,16, 13,16-3.9 Millimeters of mercuryStandard Deviation 10.01
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 1, 12 hours, n=15,16, 13,16-1.6 Millimeters of mercuryStandard Deviation 14.05
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 2, 24 hours, n=16,16, 13,162.1 Millimeters of mercuryStandard Deviation 8.51
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 2, 24 hours, n=16,16, 13,167.4 Millimeters of mercuryStandard Deviation 13.86
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP, Day 1, 2 hours, n=16,16, 13,160.3 Millimeters of mercuryStandard Deviation 7.33
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP, Day 1, 2 hours, n=16,16, 13,16-1.4 Millimeters of mercuryStandard Deviation 13.46
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 2, 24 hours, n=16,16, 13,16-2.7 Millimeters of mercuryStandard Deviation 9.76
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ASBP, Day 1, 2 hours, n=16,16, 13,164.3 Millimeters of mercuryStandard Deviation 10.7
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 1, 12 hours, n=16,16, 13,16-3.6 Millimeters of mercuryStandard Deviation 9.87
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ADBP, Day 1, 2 hours, n=16,16, 13,163.0 Millimeters of mercuryStandard Deviation 8.12
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 2, 24 hours, n=16,16, 13,160.7 Millimeters of mercuryStandard Deviation 7.6
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 1, 12 hours, n=15,16, 13,16-2.5 Millimeters of mercuryStandard Deviation 14.27
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ADBP,Day 2, 24 hours, n=16,16, 13,16-1.7 Millimeters of mercuryStandard Deviation 7.79
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ASBP,Day 1, 12 hours, n=15,16, 13,16-6.2 Millimeters of mercuryStandard Deviation 12.34
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ADBP, Day 1, 2 hours, n=16,16, 13,16-1.8 Millimeters of mercuryStandard Deviation 7.81
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ASBP,Day 2, 24 hours, n=16,16, 13,16-6.2 Millimeters of mercuryStandard Deviation 11.22
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ASBP, Day 1, 2 hours, n=16,16, 13,16-0.2 Millimeters of mercuryStandard Deviation 16.53
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part ADBP,Day 1, 12 hours, n=16,16, 13,16-3.0 Millimeters of mercuryStandard Deviation 9.27
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 2, 24 hours, n=16,16, 13,16-1.1 Millimeters of mercuryStandard Deviation 8.82
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP, Day 1, 2 hours, n=16,16, 13,16-6.2 Millimeters of mercuryStandard Deviation 11.2
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 1, 12 hours, n=15,16, 13,16-2.9 Millimeters of mercuryStandard Deviation 18.7
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ASBP,Day 2, 24 hours, n=16,16, 13,16-3.9 Millimeters of mercuryStandard Deviation 14.11
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP, Day 1, 2 hours, n=16,16, 13,16-4.4 Millimeters of mercuryStandard Deviation 8.94
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part ADBP,Day 1, 12 hours, n=16,16, 13,16-3.9 Millimeters of mercuryStandard Deviation 9.02
Secondary

Change From Baseline in Blood Pressure: Part B

SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, Pre-dose2.6 Millimeters of mercuryStandard Deviation 8.57
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, 12 hours2.4 Millimeters of mercuryStandard Deviation 11.55
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 2, Pre-dose-0.1 Millimeters of mercuryStandard Deviation 5.26
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 2, Pre-dose-1.5 Millimeters of mercuryStandard Deviation 4.55
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 4, 24 hours2.9 Millimeters of mercuryStandard Deviation 9.22
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 1, 12 hours2.7 Millimeters of mercuryStandard Deviation 7.75
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 1, 12 hours-1.7 Millimeters of mercuryStandard Deviation 5.5
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP, Day 1, 2 hours2.4 Millimeters of mercuryStandard Deviation 7.31
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, 2 hours3.1 Millimeters of mercuryStandard Deviation 7
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, Pre-dose-1.0 Millimeters of mercuryStandard Deviation 9.35
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 4, 24 hours3.0 Millimeters of mercuryStandard Deviation 5.56
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP, Day 1, 2 hours-0.5 Millimeters of mercuryStandard Deviation 7.4
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, 2 hours2.0 Millimeters of mercuryStandard Deviation 8.37
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, 12 hours-1.4 Millimeters of mercuryStandard Deviation 7.78
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, Pre-dose1.3 Millimeters of mercuryStandard Deviation 6.65
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP, Day 1, 2 hours5.4 Millimeters of mercuryStandard Deviation 7.37
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 1, 12 hours1.5 Millimeters of mercuryStandard Deviation 8.86
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 2, Pre-dose3.5 Millimeters of mercuryStandard Deviation 7.76
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, Pre-dose1.1 Millimeters of mercuryStandard Deviation 5.09
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, 2 hours5.5 Millimeters of mercuryStandard Deviation 9.51
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 3, 12 hours7.4 Millimeters of mercuryStandard Deviation 14.17
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BSBP,Day 4, 24 hours6.1 Millimeters of mercuryStandard Deviation 5.04
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP, Day 1, 2 hours2.1 Millimeters of mercuryStandard Deviation 7.16
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 1, 12 hours-2.2 Millimeters of mercuryStandard Deviation 4.59
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 2, Pre-dose2.0 Millimeters of mercuryStandard Deviation 7.47
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, 2 hours4.0 Millimeters of mercuryStandard Deviation 5.31
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 3, 12 hours-1.4 Millimeters of mercuryStandard Deviation 5.72
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part BDBP,Day 4, 24 hours4.6 Millimeters of mercuryStandard Deviation 4.77
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 3, 12 hours-2.5 Millimeters of mercuryStandard Deviation 2.81
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 2, Pre-dose-2.7 Millimeters of mercuryStandard Deviation 6.56
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 3, 2 hours-3.3 Millimeters of mercuryStandard Deviation 9.14
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 3, Pre-dose-0.7 Millimeters of mercuryStandard Deviation 14.09
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 3, Pre-dose1.3 Millimeters of mercuryStandard Deviation 4.5
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 2, Pre-dose1.8 Millimeters of mercuryStandard Deviation 6.62
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP, Day 1, 2 hours1.2 Millimeters of mercuryStandard Deviation 7.08
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 3, 2 hours-5.8 Millimeters of mercuryStandard Deviation 3.87
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 1, 12 hours1.0 Millimeters of mercuryStandard Deviation 10.73
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP, Day 1, 2 hours-4.0 Millimeters of mercuryStandard Deviation 4.2
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 4, 24 hours6.0 Millimeters of mercuryStandard Deviation 11.24
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 4, 24 hours1.3 Millimeters of mercuryStandard Deviation 6.65
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BDBP,Day 1, 12 hours-5.7 Millimeters of mercuryStandard Deviation 4.03
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part BSBP,Day 3, 12 hours3.8 Millimeters of mercuryStandard Deviation 8.21
Secondary

Change From Baseline in Blood Pressure: Part C

SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours-3.3 Millimeters of mercuryStandard Deviation 7.93
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours-3.1 Millimeters of mercuryStandard Deviation 10.04
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours4.9 Millimeters of mercuryStandard Deviation 8.02
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours-0.1 Millimeters of mercuryStandard Deviation 7.41
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours-2.1 Millimeters of mercuryStandard Deviation 7.23
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours0.4 Millimeters of mercuryStandard Deviation 7.21
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours-2.6 Millimeters of mercuryStandard Deviation 8.34
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours-0.7 Millimeters of mercuryStandard Deviation 6.43
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours1.0 Millimeters of mercuryStandard Deviation 4.88
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours-0.6 Millimeters of mercuryStandard Deviation 7.5
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours-1.4 Millimeters of mercuryStandard Deviation 6.71
Part A: MT-8hour 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours-1.1 Millimeters of mercuryStandard Deviation 6.36
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours-0.5 Millimeters of mercuryStandard Deviation 6.64
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours-3.1 Millimeters of mercuryStandard Deviation 6.53
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours2.0 Millimeters of mercuryStandard Deviation 6.92
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours-1.6 Millimeters of mercuryStandard Deviation 8.39
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours-0.6 Millimeters of mercuryStandard Deviation 6.16
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours1.4 Millimeters of mercuryStandard Deviation 12.06
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours-4.3 Millimeters of mercuryStandard Deviation 6.94
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours0.1 Millimeters of mercuryStandard Deviation 10.81
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours-3.1 Millimeters of mercuryStandard Deviation 8.5
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours2.8 Millimeters of mercuryStandard Deviation 6.37
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours-0.6 Millimeters of mercuryStandard Deviation 8.02
Part A: IR 120mg FastedChange From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours-4.9 Millimeters of mercuryStandard Deviation 9.18
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours1.1 Millimeters of mercuryStandard Deviation 16.02
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours-3.7 Millimeters of mercuryStandard Deviation 9.61
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours-7.3 Millimeters of mercuryStandard Deviation 14.92
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours2.6 Millimeters of mercuryStandard Deviation 10.84
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours-0.6 Millimeters of mercuryStandard Deviation 7.88
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours0.7 Millimeters of mercuryStandard Deviation 7.49
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CDBP, Day 1, 2 hours-1.9 Millimeters of mercuryStandard Deviation 5.5
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CSBP,Day2, 24 hours-7.5 Millimeters of mercuryStandard Deviation 10.58
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CDBP,Day1, 12 hours0.0 Millimeters of mercuryStandard Deviation 8.38
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CDBP,Day2, 24 hours2.4 Millimeters of mercuryStandard Deviation 6.21
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CSBP,Day1, 12 hours0.9 Millimeters of mercuryStandard Deviation 16.03
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Blood Pressure: Part CSBP, Day 1, 2 hours-0.2 Millimeters of mercuryStandard Deviation 11.44
Secondary

Change From Baseline in Body Temperature: Part A

Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population.

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 2 hours0.02 Degree CelsiusStandard Deviation 0.152
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 2, 24 hours0.04 Degree CelsiusStandard Deviation 0.182
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 12 hours0.07 Degree CelsiusStandard Deviation 0.139
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 2 hours0.18 Degree CelsiusStandard Deviation 0.18
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part ADay 2, 24 hours0.07 Degree CelsiusStandard Deviation 0.095
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 12 hours-0.04 Degree CelsiusStandard Deviation 0.145
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part ADay 1, 12 hours0.13 Degree CelsiusStandard Deviation 0.118
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part ADay 1, 2 hours0.05 Degree CelsiusStandard Deviation 0.145
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part ADay 2, 24 hours0.12 Degree CelsiusStandard Deviation 0.114
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 2 hours0.14 Degree CelsiusStandard Deviation 0.126
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 2, 24 hours0.12 Degree CelsiusStandard Deviation 0.161
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part ADay 1, 12 hours0.11 Degree CelsiusStandard Deviation 0.173
Secondary

Change From Baseline in Body Temperature: Part B

Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 1, 12 hours0.06 Degree CelsiusStandard Deviation 0.181
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, 2 hours-0.03 Degree CelsiusStandard Deviation 0.149
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, Pre-dose0.04 Degree CelsiusStandard Deviation 0.135
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 1, 2 hours0.03 Degree CelsiusStandard Deviation 0.298
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 4, 24 hours0.04 Degree CelsiusStandard Deviation 0.171
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, 12 hours0.01 Degree CelsiusStandard Deviation 0.191
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part BDay 2, Pre-dose0.04 Degree CelsiusStandard Deviation 0.184
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, Pre-dose0.07 Degree CelsiusStandard Deviation 0.271
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 1, 2 hours-0.01 Degree CelsiusStandard Deviation 0.233
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 1, 12 hours0.08 Degree CelsiusStandard Deviation 0.274
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 2, Pre-dose-0.04 Degree CelsiusStandard Deviation 0.158
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, 2 hours0.01 Degree CelsiusStandard Deviation 0.26
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 3, 12 hours0.05 Degree CelsiusStandard Deviation 0.242
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part BDay 4, 24 hours0.11 Degree CelsiusStandard Deviation 0.247
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 3, 2 hours-0.08 Degree CelsiusStandard Deviation 0.147
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 1, 12 hours0.07 Degree CelsiusStandard Deviation 0.082
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 4, 24 hours0.00 Degree CelsiusStandard Deviation 0.089
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 3, 12 hours0.05 Degree CelsiusStandard Deviation 0.138
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 3, Pre-dose0.23 Degree CelsiusStandard Deviation 0.151
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 2, Pre-dose0.12 Degree CelsiusStandard Deviation 0.133
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part BDay 1, 2 hours0.00 Degree CelsiusStandard Deviation 0.11
Secondary

Change From Baseline in Body Temperature: Part C

Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 12 hours0.02 Degree CelsiusStandard Deviation 0.197
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 2 hours-0.10 Degree CelsiusStandard Deviation 0.245
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 2, 24 hours-0.04 Degree CelsiusStandard Deviation 0.256
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 12 hours-0.11 Degree CelsiusStandard Deviation 0.229
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 2 hours-0.05 Degree CelsiusStandard Deviation 0.192
Part A: MT-8hour 120mg FastedChange From Baseline in Body Temperature: Part CDay 2, 24 hours0.15 Degree CelsiusStandard Deviation 0.261
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part CDay 2, 24 hours-0.00 Degree CelsiusStandard Deviation 0.239
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part CDay 1, 2 hours-0.07 Degree CelsiusStandard Deviation 0.215
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Body Temperature: Part CDay 1, 12 hours-0.05 Degree CelsiusStandard Deviation 0.271
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 12 hours0.12 Degree CelsiusStandard Deviation 0.307
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 1, 2 hours0.23 Degree CelsiusStandard Deviation 0.275
Part A: IR 120mg FastedChange From Baseline in Body Temperature: Part CDay 2, 24 hours0.10 Degree CelsiusStandard Deviation 0.278
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Body Temperature: Part CDay 1, 12 hours-0.14 Degree CelsiusStandard Deviation 0.241
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Body Temperature: Part CDay 1, 2 hours0.01 Degree CelsiusStandard Deviation 0.228
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Body Temperature: Part CDay 2, 24 hours-0.09 Degree CelsiusStandard Deviation 0.269
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Body Temperature: Part CDay 2, 24 hours-0.01 Degree CelsiusStandard Deviation 0.241
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Body Temperature: Part CDay 1, 12 hours-0.10 Degree CelsiusStandard Deviation 0.266
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Body Temperature: Part CDay 1, 2 hours0.10 Degree CelsiusStandard Deviation 0.301
Secondary

Change From Baseline in Heart Rate: Part A

Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1 Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population.

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 2 hours-4.4 Beats per minuteStandard Deviation 5.11
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 2, 24 hours1.5 Beats per minuteStandard Deviation 9.41
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 12 hours4.8 Beats per minuteStandard Deviation 6.06
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 2 hours-0.3 Beats per minuteStandard Deviation 4.88
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part ADay 2, 24 hours-2.1 Beats per minuteStandard Deviation 6.31
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 12 hours5.2 Beats per minuteStandard Deviation 3.94
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part ADay 1, 12 hours5.8 Beats per minuteStandard Deviation 5.57
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part ADay 1, 2 hours-2.5 Beats per minuteStandard Deviation 7.62
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part ADay 2, 24 hours0.6 Beats per minuteStandard Deviation 7.14
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 2 hours3.9 Beats per minuteStandard Deviation 7.48
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 2, 24 hours0.9 Beats per minuteStandard Deviation 7.62
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part ADay 1, 12 hours7.5 Beats per minuteStandard Deviation 9.93
Secondary

Change From Baseline in Heart Rate: Part B

Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 1, 12 hours10.0 Beats per minuteStandard Deviation 4
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, 2 hours1.2 Beats per minuteStandard Deviation 5.37
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, Pre-dose2.3 Beats per minuteStandard Deviation 4.74
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 1, 2 hours0.0 Beats per minuteStandard Deviation 5.5
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 4, 24 hours4.7 Beats per minuteStandard Deviation 8.64
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, 12 hours8.6 Beats per minuteStandard Deviation 4.58
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part BDay 2, Pre-dose-0.1 Beats per minuteStandard Deviation 4.68
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, Pre-dose-0.1 Beats per minuteStandard Deviation 5.88
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 1, 2 hours-2.4 Beats per minuteStandard Deviation 5.38
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 1, 12 hours8.8 Beats per minuteStandard Deviation 5.22
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 2, Pre-dose-0.8 Beats per minuteStandard Deviation 6.37
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, 2 hours-0.3 Beats per minuteStandard Deviation 5.36
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 3, 12 hours10.6 Beats per minuteStandard Deviation 7.26
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part BDay 4, 24 hours6.7 Beats per minuteStandard Deviation 10.01
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 3, 2 hours4.0 Beats per minuteStandard Deviation 2.28
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 1, 12 hours10.5 Beats per minuteStandard Deviation 3.78
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 4, 24 hours0.3 Beats per minuteStandard Deviation 2.58
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 3, 12 hours7.7 Beats per minuteStandard Deviation 5.28
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 3, Pre-dose1.5 Beats per minuteStandard Deviation 5.43
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 2, Pre-dose-1.8 Beats per minuteStandard Deviation 2.71
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part BDay 1, 2 hours7.3 Beats per minuteStandard Deviation 6.89
Secondary

Change From Baseline in Heart Rate: Part C

Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 12 hours6.8 Beats per minuteStandard Deviation 6.2
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 2 hours2.1 Beats per minuteStandard Deviation 6.94
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 2, 24 hours1.8 Beats per minuteStandard Deviation 5.44
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 12 hours6.5 Beats per minuteStandard Deviation 9.73
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 2 hours-5.3 Beats per minuteStandard Deviation 6.19
Part A: MT-8hour 120mg FastedChange From Baseline in Heart Rate: Part CDay 2, 24 hours0.1 Beats per minuteStandard Deviation 6.41
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part CDay 1, 12 hours11.2 Beats per minuteStandard Deviation 9.65
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part CDay 1, 2 hours0.0 Beats per minuteStandard Deviation 6.86
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Heart Rate: Part CDay 2, 24 hours-0.4 Beats per minuteStandard Deviation 3.77
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 12 hours10.3 Beats per minuteStandard Deviation 6.94
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 1, 2 hours7.3 Beats per minuteStandard Deviation 6.56
Part A: IR 120mg FastedChange From Baseline in Heart Rate: Part CDay 2, 24 hours0.4 Beats per minuteStandard Deviation 5.8
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Heart Rate: Part CDay 1, 12 hours9.3 Beats per minuteStandard Deviation 8.28
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Heart Rate: Part CDay 1, 2 hours8.2 Beats per minuteStandard Deviation 5.72
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Heart Rate: Part CDay 2, 24 hours-0.9 Beats per minuteStandard Deviation 6.19
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Heart Rate: Part CDay 1, 2 hours8.2 Beats per minuteStandard Deviation 7.32
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Heart Rate: Part CDay 2, 24 hours1.6 Beats per minuteStandard Deviation 7.74
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Heart Rate: Part CDay 1, 12 hours8.6 Beats per minuteStandard Deviation 6.99
Secondary

Change From Baseline in Respiration Rate: Part A

Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population.

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 2 hours-0.4 Breaths per minuteStandard Deviation 1.67
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 2, 24 hours1.3 Breaths per minuteStandard Deviation 2.15
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 12 hours-0.6 Breaths per minuteStandard Deviation 1.71
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 2 hours0.8 Breaths per minuteStandard Deviation 1.65
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part ADay 2, 24 hours-0.1 Breaths per minuteStandard Deviation 1.54
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 12 hours-0.1 Breaths per minuteStandard Deviation 1.82
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part ADay 1, 12 hours-0.2 Breaths per minuteStandard Deviation 1.21
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part ADay 1, 2 hours0.0 Breaths per minuteStandard Deviation 1
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part ADay 2, 24 hours-1.5 Breaths per minuteStandard Deviation 1.51
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 2 hours-1.5 Breaths per minuteStandard Deviation 2.5
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 2, 24 hours-1.4 Breaths per minuteStandard Deviation 2.13
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part ADay 1, 12 hours-2.4 Breaths per minuteStandard Deviation 2.63
Secondary

Change From Baseline in Respiration Rate: Part B

Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value

Time frame: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4 24 hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 1, 12 hours-0.1 Breaths per minuteStandard Deviation 1.37
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, 2 hours-1.3 Breaths per minuteStandard Deviation 2.36
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, Pre-dose-0.7 Breaths per minuteStandard Deviation 2.67
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 1, 2 hours0.5 Breaths per minuteStandard Deviation 2.27
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 4, 24 hours-0.8 Breaths per minuteStandard Deviation 1.87
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, 12 hours0.3 Breaths per minuteStandard Deviation 3.02
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part BDay 2, Pre-dose-0.3 Breaths per minuteStandard Deviation 1.49
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, Pre-dose-0.5 Breaths per minuteStandard Deviation 1.43
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 1, 2 hours-2.0 Breaths per minuteStandard Deviation 2
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 1, 12 hours-2.5 Breaths per minuteStandard Deviation 2.17
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 2, Pre-dose-0.5 Breaths per minuteStandard Deviation 2.07
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, 2 hours-1.0 Breaths per minuteStandard Deviation 2.21
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 3, 12 hours-1.3 Breaths per minuteStandard Deviation 2.16
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part BDay 4, 24 hours-1.0 Breaths per minuteStandard Deviation 1.89
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 3, 2 hours-0.7 Breaths per minuteStandard Deviation 2.16
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 1, 12 hours-1.5 Breaths per minuteStandard Deviation 2.35
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 4, 24 hours-0.3 Breaths per minuteStandard Deviation 2.42
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 3, 12 hours-0.8 Breaths per minuteStandard Deviation 1.33
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 3, Pre-dose1.5 Breaths per minuteStandard Deviation 2.26
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 2, Pre-dose-0.5 Breaths per minuteStandard Deviation 2.74
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part BDay 1, 2 hours-1.2 Breaths per minuteStandard Deviation 3.54
Secondary

Change From Baseline in Respiration Rate: Part C

Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 12 hours1.1 Breaths per minuteStandard Deviation 2.59
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 2 hours1.7 Breaths per minuteStandard Deviation 3.37
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 2, 24 hours1.6 Breaths per minuteStandard Deviation 3.25
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 12 hours1.0 Breaths per minuteStandard Deviation 2.85
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 2 hours0.6 Breaths per minuteStandard Deviation 2.03
Part A: MT-8hour 120mg FastedChange From Baseline in Respiration Rate: Part CDay 2, 24 hours0.4 Breaths per minuteStandard Deviation 3.07
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part CDay 1, 12 hours0.6 Breaths per minuteStandard Deviation 2.66
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part CDay 1, 2 hours0.9 Breaths per minuteStandard Deviation 2.9
Part A: MT-12hour 120mg Fed (High Fat)Change From Baseline in Respiration Rate: Part CDay 2, 24 hours0.6 Breaths per minuteStandard Deviation 4
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 12 hours-1.1 Breaths per minuteStandard Deviation 2.9
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 1, 2 hours-1.1 Breaths per minuteStandard Deviation 2.95
Part A: IR 120mg FastedChange From Baseline in Respiration Rate: Part CDay 2, 24 hours-2.2 Breaths per minuteStandard Deviation 2.66
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Respiration Rate: Part CDay 1, 12 hours-0.3 Breaths per minuteStandard Deviation 2.61
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Respiration Rate: Part CDay 1, 2 hours1.8 Breaths per minuteStandard Deviation 1.74
Part C:MM-12h 480mg Delayed Fed(Standard)Change From Baseline in Respiration Rate: Part CDay 2, 24 hours1.8 Breaths per minuteStandard Deviation 2.31
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Respiration Rate: Part CDay 1, 2 hours0.1 Breaths per minuteStandard Deviation 2.76
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Respiration Rate: Part CDay 2, 24 hours0.4 Breaths per minuteStandard Deviation 3.34
Part C: MM-12h 240mg Delayed Fed(High Fat)Change From Baseline in Respiration Rate: Part CDay 1, 12 hours0.5 Breaths per minuteStandard Deviation 1.51
Secondary

Cmax of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of Cmax

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours

Population: PK Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedCmax of GSK2982772 After Meal in Part C1.547 Microgram/milliliterGeometric Coefficient of Variation 40.8
Part A: MT-8hour 120mg FastedCmax of GSK2982772 After Meal in Part C1.064 Microgram/milliliterGeometric Coefficient of Variation 62.6
Part A: MT-12hour 120mg Fed (High Fat)Cmax of GSK2982772 After Meal in Part C3.151 Microgram/milliliterGeometric Coefficient of Variation 32.5
Secondary

Cmax of GSK2982772 in Part B

Blood samples were collected at indicated time points for analysis of Cmax

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3

Population: PK Population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: IR 120mg FastedCmax of GSK2982772 in Part BDay 10.417 Microgram/milliliterGeometric Coefficient of Variation 25.5
Part A: IR 120mg FastedCmax of GSK2982772 in Part BDay 30.398 Microgram/milliliterGeometric Coefficient of Variation 32.9
Part A: MT-8hour 120mg FastedCmax of GSK2982772 in Part BDay 10.707 Microgram/milliliterGeometric Coefficient of Variation 44.7
Part A: MT-8hour 120mg FastedCmax of GSK2982772 in Part BDay 30.794 Microgram/milliliterGeometric Coefficient of Variation 35.7
Part A: MT-12hour 120mg Fed (High Fat)Cmax of GSK2982772 in Part BDay 10.888 Microgram/milliliterGeometric Coefficient of Variation 14.1
Part A: MT-12hour 120mg Fed (High Fat)Cmax of GSK2982772 in Part BDay 31.080 Microgram/milliliterGeometric Coefficient of Variation 40.4
Secondary

Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A

Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after a high fat meal. Frel for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT Fed formulation (test) / Geometric mean of AUC (0-inf) of MT Fasted Formulation (reference) multiplied by 100.

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A123.64 Percentage bioavailability
Secondary

Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after meal. Frel for Auc (0-t) was calculated as Geometric mean of AUC (0-t) of MM Fed formulation (fed) / Geometric mean of AUC (0-t) of MM Fasted Formulation (fasted) multiplied by 100.

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C94.69 Percentage bioavailability
Part A: MT-8hour 120mg FastedFrelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C113.51 Percentage bioavailability
Part A: MT-12hour 120mg Fed (High Fat)Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C91.13 Percentage bioavailability
Secondary

Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A

Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772 after a high fat meal. Frel for Cmax was calculated as Geometric mean of Cmax of MT Fed formulation (test) / Geometric mean of Cmax of MT Fasted Formulation (reference) multiplied by 100.

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population. Only those participants with data available at specified timepoint were analyzed

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A225.07 Percentage bioavailability
Secondary

Frelformulation Based on Cmax of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 after meal. Frel for Cmax was calculated as Geometric mean of Cmax of MM Fed formulation (test) / Geometric mean of Cmax of MM Fasted Formulation (reference) multiplied by 100.

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population

ArmMeasureValue (NUMBER)
Part A: IR 120mg FastedFrelformulation Based on Cmax of GSK2982772 After Meal in Part C76.56 Percentage bioavailability
Part A: MT-8hour 120mg FastedFrelformulation Based on Cmax of GSK2982772 After Meal in Part C156.77 Percentage bioavailability
Part A: MT-12hour 120mg Fed (High Fat)Frelformulation Based on Cmax of GSK2982772 After Meal in Part C113.81 Percentage bioavailability
Secondary

Number of Participants Abnormal ECG Findings: Part B

Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 22

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part BAbnormal, not clinically significant4 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part BAbnormal, clinically significant0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal ECG Findings: Part BAbnormal, not clinically significant4 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal ECG Findings: Part BAbnormal, clinically significant0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal ECG Findings: Part BAbnormal, not clinically significant2 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal ECG Findings: Part BAbnormal, clinically significant0 Participants
Secondary

Number of Participants Abnormal ECG Findings: Part C

Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant1 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant4 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant7 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant5 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant6 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants Abnormal ECG Findings: Part CAbnormal, not clinically significant3 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants Abnormal ECG Findings: Part CAbnormal, clinically significant0 Participants
Secondary

Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A

Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and Corrected QT (QTc) intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, not clinically significant6 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, clinically significant1 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, clinically significant0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, not clinically significant8 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, not clinically significant9 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, clinically significant0 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, not clinically significant9 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal Electrocardiogram (ECG) Findings: Part AAbnormal, clinically significant0 Participants
Secondary

Number of Participants Abnormal Urinalysis Dipstick Results: Part A

Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part A0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part A0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal Urinalysis Dipstick Results: Part A0 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part A0 Participants
Secondary

Number of Participants Abnormal Urinalysis Dipstick Results: Part B

Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.

Time frame: Up to Day 22

Population: Safety Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part B0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part B0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal Urinalysis Dipstick Results: Part B0 Participants
Secondary

Number of Participants Abnormal Urinalysis Dipstick Results: Part C

Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Part A: IR 120mg FastedNumber of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants Abnormal Urinalysis Dipstick Results: Part C0 Participants
Secondary

Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A

An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before. All participants who receive at least 1 dose of study treatment and were included in Safety Population. Participants will be analyzed according to the treatment they actually received.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny AEs4 Participants
Part A: IR 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny SAEs0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny SAEs1 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny AEs5 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny AEs1 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny SAEs0 Participants
Part A: IR 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny AEs2 Participants
Part A: IR 120mg FastedNumber of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part AAny SAEs0 Participants
Secondary

Number of Participants With AE and SAE in Part B

An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Time frame: Up to Day 22

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part BAny AEs1 Participants
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part BAny SAEs0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With AE and SAE in Part BAny AEs3 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With AE and SAE in Part BAny SAEs0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With AE and SAE in Part BAny AEs1 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With AE and SAE in Part BAny SAEs0 Participants
Secondary

Number of Participants With AE and SAE in Part C

An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part CAny AEs3 Participants
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part CAny SAEs0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With AE and SAE in Part CAny AEs3 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With AE and SAE in Part CAny SAEs0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With AE and SAE in Part CAny AEs3 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With AE and SAE in Part CAny SAEs0 Participants
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part CAny AEs4 Participants
Part A: IR 120mg FastedNumber of Participants With AE and SAE in Part CAny SAEs0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With AE and SAE in Part CAny AEs2 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With AE and SAE in Part CAny SAEs0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With AE and SAE in Part CAny AEs1 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With AE and SAE in Part CAny SAEs0 Participants
Secondary

Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A

Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, normal or no change1616 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, high1 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, normal or no change1613 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, normal or no change1616 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, high1 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, normal or no change1616 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ASodium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ATotal Bilirubin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAlbumin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AAST, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALP, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AALT, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACreatinine, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part AGlucose, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part APotassium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part ACalcium, high0 Participants
Secondary

Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B

Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 22

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, normal or no change10 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BTotal Bilirubin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCalcium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BGlucose, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAlbumin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BSodium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BPotassium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALP, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BCreatinine, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BAST, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part BALT, low0 Participants
Secondary

Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C

Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change15 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change15 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high1 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high1 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change14 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, high14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CGlucose, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALT, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCalcium, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CTotal Bilirubin, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CCreatinine, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CPotassium, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAST, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CAlbumin, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CALP, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part CSodium, low0 Participants
Secondary

Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A

Blood samples were collected to analyze hematology parameters like platelet count, white blood cell (WBC) count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, low1 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, low1 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, normal or no change16 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, normal or no change13 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, low2 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, normal or no change11 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, low1 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, normal or no change12 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part APlatelet count, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHematocrit, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ATotal Neutrophils, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AWBC, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part ALymphocytes, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part AHemoglobin, high0 Participants
Secondary

Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B

Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 22

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, normal or no change10 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, normal or no change10 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BLymphocytes, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BPlatelet count, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHematocrit, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BHemoglobin, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BTotal Neutrophils, normal or no change6 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part BWBC, normal or no change6 Participants
Secondary

Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C

Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 43

Population: Safety Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change15 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change15 Participants
Part A: MT-8hour 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change16 Participants
Part A: MT-12hour 120mg Fed (High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change16 Participants
Part A: IR 120mg FastedNumber of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change15 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part C:MM-12h 480mg Delayed Fed(Standard)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CWBC, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, normal or no change14 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHemoglobin, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CHematocrit, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CLymphocytes, low0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CPlatelet count, high0 Participants
Part C: MM-12h 240mg Delayed Fed(High Fat)Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part CTotal Neutrophils, high0 Participants
Secondary

Tmax of GSK2982772 After Meal in Part C

Blood samples were collected at indicated time points for analysis of Tmax of GSK2982772 after meal.

Time frame: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose

Population: PK Population.

ArmMeasureValue (MEDIAN)
Part A: IR 120mg FastedTmax of GSK2982772 After Meal in Part C4.000 Hours
Part A: MT-8hour 120mg FastedTmax of GSK2982772 After Meal in Part C4.000 Hours
Part A: MT-12hour 120mg Fed (High Fat)Tmax of GSK2982772 After Meal in Part C5.017 Hours
Secondary

Tmax of GSK2982772 in Part B

Blood samples were collected at indicated time points for analysis of Tmax

Time frame: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3

Population: PK Population.

ArmMeasureGroupValue (MEDIAN)
Part A: IR 120mg FastedTmax of GSK2982772 in Part BDay 14.058 Hours
Part A: IR 120mg FastedTmax of GSK2982772 in Part BDay 34.000 Hours
Part A: MT-8hour 120mg FastedTmax of GSK2982772 in Part BDay 14.067 Hours
Part A: MT-8hour 120mg FastedTmax of GSK2982772 in Part BDay 35.025 Hours
Part A: MT-12hour 120mg Fed (High Fat)Tmax of GSK2982772 in Part BDay 14.000 Hours
Part A: MT-12hour 120mg Fed (High Fat)Tmax of GSK2982772 in Part BDay 34.000 Hours

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026