Autoimmune Diseases
Conditions
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | 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. |
| AUC(0-inf) of GSK2982772 in MT Formulation :Part A | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 A | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t) |
| AUC(0-t) of GSK2982772 in MT Formulation: Part A | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 A | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24) |
| AUC(0-24) of GSK2982772 in MT Formulation: Part A | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 A | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12) |
| AUC(0-12) of GSK2982772 in MT Formulation: Part A | Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose | Blood 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 A | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for Cmax |
| Cmax of GSK2982772 in MT Formulation: Part A | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for Cmax |
| Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A | 12 hours post-dose | Blood samples were collected from participants at indicated time points and analyzed for C12hour. |
| Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A | 24 hours post-dose | Blood 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 A | 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) | 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 A | 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) | 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 A | 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) | 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 A | 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 | 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. |
| Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A | Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | 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. |
| Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | 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 to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A | Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose | Blood samples were collected at indicated time points for analysis of Tmax. |
| Tmax of GSK2982772 in MT Formulation: Part A | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | Blood samples were collected at indicated time points for analysis of Tmax. |
| AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood 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 State | Pre-dose, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood 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 State | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood 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 State | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose | Blood 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 State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose | Blood 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 State | Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC (0-12) |
| Cmax of GSK2982772 for IR Formulation in Part C: Fasted State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for analysis of Cmax |
| Cmax of GSK2982772 for MM Formulation in Part C: Fasted State | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood samples were collected at indicated time points for analysis of Cmax |
| C12 of GSK2982772 in Part C: Fasted State | 12 hours post-dose | Blood samples was collected at indicated time point for analysis of C12 |
| C24 of GSK2982772 in Part C: Fasted State | 24 hours post-dose | Blood 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 State | Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | 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. |
| Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State | Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose | 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. |
| Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State | Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State | 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) | 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 State | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Respiration Rate: Part C | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Change From Baseline in Body Temperature: Part C | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| AUC(0-24) of GSK2982772 in Part B | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3 | Blood samples were collected at indicated time points for analysis of AUC (0-24) |
| Cmax of GSK2982772 in Part B | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3 | Blood samples were collected at indicated time points for analysis of Cmax |
| Tmax of GSK2982772 in Part B | Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3 | Blood samples were collected at indicated time points for analysis of Tmax |
| AUC (0-24) of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC (0-24) |
| Cmax of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours | Blood samples were collected at indicated time points for analysis of Cmax |
| C12 of GSK2982772 After Meal in Part C | 12 hours post-dose | Blood samples were collected at indicated time points for analysis of C12 |
| AUC(0-t) of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC (0-t) |
| AUC(0-inf) of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC (0-inf) after meal. |
| AUC(0-12) of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, and 12 hours post-dose | Blood 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 C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Frelformulation Based on Cmax of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | 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. |
| Tmax of GSK2982772 After Meal in Part C | Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose | Blood 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 A | Up to Day 43 | 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. |
| Number of Participants With AE and SAE in Part B | Up to Day 22 | 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. |
| Number of Participants With AE and SAE in Part C | Up to Day 43 | 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. |
| Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Up to Day 43 | 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. |
| Number of Participants Abnormal Urinalysis Dipstick Results: Part B | Up to Day 22 | 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. |
| Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Up to Day 43 | 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. |
| Number of Participants Abnormal Urinalysis Dipstick Results: Part A | Up to Day 43 | 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. |
| Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Up to Day 22 | 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. |
| Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Up to Day 22 | 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. |
| Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Up to Day 43 | 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. |
| Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Up to Day 43 | 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. |
| Number of Participants Abnormal Urinalysis Dipstick Results: Part C | Up to Day 43 | 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. |
| Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Up to Day 43 | 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. |
| Number of Participants Abnormal ECG Findings: Part B | Up to Day 22 | 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. |
| Number of Participants Abnormal ECG Findings: Part C | Up to Day 43 | 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. |
| Change From Baseline in Blood Pressure: Part A | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Change From Baseline in Heart Rate: Part A | Baseline (Day 1 Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Change From Baseline in Respiration Rate: Part A | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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 |
| Change From Baseline in Body Temperature: Part A | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Change From Baseline in Blood Pressure: Part B | 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 | 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. |
| Change From Baseline in Heart Rate: Part B | 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 | 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. |
| Change From Baseline in Respiration Rate: Part B | 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 | 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 |
| Change From Baseline in Body Temperature: Part B | 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 | 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. |
| Change From Baseline in Blood Pressure: Part C | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
| Change From Baseline in Heart Rate: Part C | Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Part A: Period 1(2 Days) | Withdrawal by Subject | 1 | 0 | 0 |
| Part A: Washout Period (7 Days) | Adverse Event | 1 | 0 | 0 |
| Part A: Washout Period (7 Days) | Withdrawal by Subject | 1 | 0 | 0 |
| Part B: Washout (7 Days) | Withdrawal by Subject | 0 | 2 | 0 |
| Part C Washout Period (7 Days) | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | MT-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 DF | Total |
|---|---|---|---|---|
| Age, Continuous | 49.2 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 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 18 Participants | 10 Participants | 14 Participants | 42 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 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 / 16 | 1 / 16 | 0 / 13 | 0 / 16 | 0 / 10 | 0 / 10 | 0 / 6 | 0 / 15 | 0 / 15 | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 4 / 16 | 5 / 16 | 1 / 13 | 2 / 16 | 1 / 10 | 3 / 10 | 1 / 6 | 3 / 15 | 3 / 15 | 3 / 16 | 4 / 16 | 2 / 15 | 1 / 14 |
| serious Total, serious adverse events | 0 / 16 | 1 / 16 | 0 / 13 | 0 / 16 | 0 / 10 | 0 / 10 | 0 / 6 | 0 / 15 | 0 / 15 | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 14 |
Outcome results
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Area Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part A | 5.967 Hours*microgram per milliliter | Geometric Coefficient of Variation 38.4 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part A | 6.256 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.2 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A | 6.305 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.4 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part A | 6.258 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.2 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted State | 13.500 Hours*microgram per milliliter | Geometric Coefficient of Variation 26.3 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State | 6.096 Hours*microgram per milliliter | Geometric Coefficient of Variation 32.8 |
| Part A: MT-8hour 120mg Fasted | AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State | 12.508 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.1 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-12) of GSK2982772 in MT Formulation: Part A | 2.106 Hours*microgram per milliliter | Geometric Coefficient of Variation 45.1 |
| Part A: MT-8hour 120mg Fasted | AUC(0-12) of GSK2982772 in MT Formulation: Part A | 3.066 Hours*microgram per milliliter | Geometric Coefficient of Variation 47.7 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-12) of GSK2982772 in MT Formulation: Part A | 3.573 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.8 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted State | 14.619 Hours*microgram per milliliter | Geometric Coefficient of Variation 25.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State | 8.769 Hours*microgram per milliliter | Geometric Coefficient of Variation 30.9 |
| Part A: MT-8hour 120mg Fasted | AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State | 18.177 Hours*microgram per milliliter | Geometric Coefficient of Variation 31.5 |
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-24) of GSK2982772 in MT Formulation: Part A | 3.558 Hours*microgram per milliliter | Geometric Coefficient of Variation 43.6 |
| Part A: MT-8hour 120mg Fasted | AUC(0-24) of GSK2982772 in MT Formulation: Part A | 4.255 Hours*microgram per milliliter | Geometric Coefficient of Variation 49.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-24) of GSK2982772 in MT Formulation: Part A | 4.580 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.5 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State | 14.797 Hours*microgram per milliliter | Geometric Coefficient of Variation 26.3 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State | 13.417 Hours*microgram per milliliter | Geometric Coefficient of Variation 23.4 |
| Part A: MT-8hour 120mg Fasted | AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State | 22.493 Hours*microgram per milliliter | Geometric Coefficient of Variation 51.3 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-inf) of GSK2982772 in MT Formulation :Part A | 3.852 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.4 |
| Part A: MT-8hour 120mg Fasted | AUC(0-inf) of GSK2982772 in MT Formulation :Part A | 4.482 Hours*microgram per milliliter | Geometric Coefficient of Variation 47.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-inf) of GSK2982772 in MT Formulation :Part A | 5.314 Hours*microgram per milliliter | Geometric Coefficient of Variation 39.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted State | 14.621 Hours*microgram per milliliter | Geometric Coefficient of Variation 25.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State | 9.676 Hours*microgram per milliliter | Geometric Coefficient of Variation 29.6 |
| Part A: MT-8hour 120mg Fasted | AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State | 20.009 Hours*microgram per milliliter | Geometric Coefficient of Variation 29.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-t) of GSK2982772 in MT Formulation: Part A | 3.805 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.3 |
| Part A: MT-8hour 120mg Fasted | AUC(0-t) of GSK2982772 in MT Formulation: Part A | 4.449 Hours*microgram per milliliter | Geometric Coefficient of Variation 49.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-t) of GSK2982772 in MT Formulation: Part A | 4.720 Hours*microgram per milliliter | Geometric Coefficient of Variation 38.4 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | C12 of GSK2982772 in Part C: Fasted State | 0.197 Microgram per milliliter | Geometric Coefficient of Variation 62.9 |
| Part A: MT-8hour 120mg Fasted | C12 of GSK2982772 in Part C: Fasted State | 0.346 Microgram per milliliter | Geometric Coefficient of Variation 41.7 |
| Part A: MT-12hour 120mg Fed (High Fat) | C12 of GSK2982772 in Part C: Fasted State | 0.671 Microgram per milliliter | Geometric Coefficient of Variation 42.3 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | C24 of GSK2982772 in Part C: Fasted State | 0.025 Microgram per milliliter | Geometric Coefficient of Variation 54.9 |
| Part A: MT-8hour 120mg Fasted | C24 of GSK2982772 in Part C: Fasted State | 0.162 Microgram per milliliter | Geometric Coefficient of Variation 52.6 |
| Part A: MT-12hour 120mg Fed (High Fat) | C24 of GSK2982772 in Part C: Fasted State | 0.351 Microgram per milliliter | Geometric Coefficient of Variation 52.5 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Cmax of GSK2982772 for IR Formulation in Part C: Fasted State | 2.938 Microgram per milliliter | Geometric Coefficient of Variation 25.2 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Cmax of GSK2982772 for MM Formulation in Part C: Fasted State | 0.918 Microgram per milliliter | Geometric Coefficient of Variation 34.2 |
| Part A: MT-8hour 120mg Fasted | Cmax of GSK2982772 for MM Formulation in Part C: Fasted State | 2.010 Microgram per milliliter | Geometric Coefficient of Variation 50.1 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Cmax of GSK2982772 in MT Formulation: Part A | 0.277 Microgram per milliliter | Geometric Coefficient of Variation 58.8 |
| Part A: MT-8hour 120mg Fasted | Cmax of GSK2982772 in MT Formulation: Part A | 0.439 Microgram per milliliter | Geometric Coefficient of Variation 54.9 |
| Part A: MT-12hour 120mg Fed (High Fat) | Cmax of GSK2982772 in MT Formulation: Part A | 0.624 Microgram per milliliter | Geometric Coefficient of Variation 49.4 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A | 0.220 Microgram per milliliter | Geometric Coefficient of Variation 52.6 |
| Part A: MT-8hour 120mg Fasted | Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A | 0.209 Microgram per milliliter | Geometric Coefficient of Variation 56.2 |
| Part A: MT-12hour 120mg Fed (High Fat) | Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A | 0.208 Microgram per milliliter | Geometric Coefficient of Variation 53.1 |
| Part A: IR 120mg Fasted | Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A | 0.045 Microgram per milliliter | Geometric Coefficient of Variation 81.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A | 0.058 Microgram per milliliter | Geometric Coefficient of Variation 73.2 |
| Part A: MT-8hour 120mg Fasted | Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A | 0.046 Microgram per milliliter | Geometric Coefficient of Variation 69.5 |
| Part A: MT-12hour 120mg Fed (High Fat) | Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A | 0.030 Microgram per milliliter | Geometric Coefficient of Variation 46.6 |
| Part A: IR 120mg Fasted | Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A | 0.006 Microgram per milliliter | Geometric Coefficient of Variation 108.8 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on AUC (0-24) of GSK2982772 in Part A | 68.18 Percentage bioavailability |
| Part A: MT-8hour 120mg Fasted | Frelformulation Based on AUC (0-24) of GSK2982772 in Part A | 57.54 Percentage bioavailability |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted State | 59.98 Percentage bioavailability |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State | 66.18 Percentage bioavailability |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on Cmax of GSK2982772 in Part A | 32.13 Percentage bioavailability |
| Part A: MT-8hour 120mg Fasted | Frelformulation Based on Cmax of GSK2982772 in Part A | 20.39 Percentage bioavailability |
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Maximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part A | 1.375 Microgram per milliliter | Geometric Coefficient of Variation 40.1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted State | 17.158 Ratio | Standard Deviation 7.9158 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State | 2.892 Ratio | Standard Deviation 1.2572 |
| Part A: MT-8hour 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State | 3.551 Ratio | Standard Deviation 2.2615 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 in IR Formulation: Part A | 36.485 Ratio | Standard Deviation 20.9265 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A | 1.284 Ratio | Standard Deviation 0.2468 |
| Part A: MT-8hour 120mg Fasted | Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A | 2.265 Ratio | Standard Deviation 0.9119 |
| Part A: MT-12hour 120mg Fed (High Fat) | Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A | 3.240 Ratio | Standard Deviation 1.225 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State | 138.239 Ratio | Standard Deviation 76.3996 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State | 6.026 Ratio | Standard Deviation 2.1936 |
| Part A: MT-8hour 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State | 7.991 Ratio | Standard Deviation 10.6319 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A | 312.851 Ratio | Standard Deviation 221.764 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A | 6.119 Ratio | Standard Deviation 5.1507 |
| Part A: MT-8hour 120mg Fasted | Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A | 10.790 Ratio | Standard Deviation 4.9019 |
| Part A: MT-12hour 120mg Fed (High Fat) | Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A | 22.915 Ratio | Standard Deviation 11.7978 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A | 72.77 Percentage bioavailability |
| Part A: MT-8hour 120mg Fasted | Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A | 60.53 Percentage bioavailability |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: IR 120mg Fasted | Time to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A | 2.000 Hours |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: IR 120mg Fasted | Tmax of GSK2982772 in MT Formulation: Part A | 10.000 Hours |
| Part A: MT-8hour 120mg Fasted | Tmax of GSK2982772 in MT Formulation: Part A | 4.000 Hours |
| Part A: MT-12hour 120mg Fed (High Fat) | Tmax of GSK2982772 in MT Formulation: Part A | 6.000 Hours |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-12) of GSK2982772 After Meal in Part C | 17.111 Hours*microgram/milliliter | Geometric Coefficient of Variation 45 |
| Part A: MT-8hour 120mg Fasted | AUC(0-12) of GSK2982772 After Meal in Part C | 10.241 Hours*microgram/milliliter | Geometric Coefficient of Variation 45.9 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-12) of GSK2982772 After Meal in Part C | 6.771 Hours*microgram/milliliter | Geometric Coefficient of Variation 56.7 |
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC (0-24) of GSK2982772 After Meal in Part C | 17.505 Hours*microgram/milliliter | Geometric Coefficient of Variation 29.5 |
| Part A: MT-8hour 120mg Fasted | AUC (0-24) of GSK2982772 After Meal in Part C | 8.734 Hours*microgram/milliliter | Geometric Coefficient of Variation 47.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC (0-24) of GSK2982772 After Meal in Part C | 21.543 Hours*microgram/milliliter | Geometric Coefficient of Variation 39.2 |
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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-24) of GSK2982772 in Part B | Day 1, n=10, 9, 5 | 4.669 Hours*microgram/milliliter | Geometric Coefficient of Variation 26.5 |
| Part A: IR 120mg Fasted | AUC(0-24) of GSK2982772 in Part B | Day 3, n=10, 10, 6 | 5.010 Hours*microgram/milliliter | Geometric Coefficient of Variation 32 |
| Part A: MT-8hour 120mg Fasted | AUC(0-24) of GSK2982772 in Part B | Day 1, n=10, 9, 5 | 8.807 Hours*microgram/milliliter | Geometric Coefficient of Variation 34.3 |
| Part A: MT-8hour 120mg Fasted | AUC(0-24) of GSK2982772 in Part B | Day 3, n=10, 10, 6 | 9.867 Hours*microgram/milliliter | Geometric Coefficient of Variation 30.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-24) of GSK2982772 in Part B | Day 1, n=10, 9, 5 | 9.662 Hours*microgram/milliliter | Geometric Coefficient of Variation 33.8 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-24) of GSK2982772 in Part B | Day 3, n=10, 10, 6 | 10.948 Hours*microgram/milliliter | Geometric Coefficient of Variation 37.7 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-inf) of GSK2982772 After Meal in Part C | 18.941 Hours*microgram/milliliter | Geometric Coefficient of Variation 36.5 |
| Part A: MT-8hour 120mg Fasted | AUC(0-inf) of GSK2982772 After Meal in Part C | 9.995 Hours*microgram/milliliter | Geometric Coefficient of Variation 62.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-inf) of GSK2982772 After Meal in Part C | 24.367 Hours*microgram/milliliter | Geometric Coefficient of Variation 49.2 |
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | AUC(0-t) of GSK2982772 After Meal in Part C | 19.147 Hours*microgram/milliliter | Geometric Coefficient of Variation 28 |
| Part A: MT-8hour 120mg Fasted | AUC(0-t) of GSK2982772 After Meal in Part C | 9.202 Hours*microgram/milliliter | Geometric Coefficient of Variation 46.4 |
| Part A: MT-12hour 120mg Fed (High Fat) | AUC(0-t) of GSK2982772 After Meal in Part C | 22.712 Hours*microgram/milliliter | Geometric Coefficient of Variation 36.2 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | C12 of GSK2982772 After Meal in Part C | 0.706 Microgram/milliliter | Geometric Coefficient of Variation 72.7 |
| Part A: MT-8hour 120mg Fasted | C12 of GSK2982772 After Meal in Part C | 0.739 Microgram/milliliter | Geometric Coefficient of Variation 37.1 |
| Part A: MT-12hour 120mg Fed (High Fat) | C12 of GSK2982772 After Meal in Part C | 0.317 Microgram/milliliter | Geometric Coefficient of Variation 49.5 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 1, 12 hours, n=16,16, 13,16 | -3.9 Millimeters of mercury | Standard Deviation 10.01 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 1, 12 hours, n=15,16, 13,16 | -1.6 Millimeters of mercury | Standard Deviation 14.05 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 2, 24 hours, n=16,16, 13,16 | 2.1 Millimeters of mercury | Standard Deviation 8.51 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 2, 24 hours, n=16,16, 13,16 | 7.4 Millimeters of mercury | Standard Deviation 13.86 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP, Day 1, 2 hours, n=16,16, 13,16 | 0.3 Millimeters of mercury | Standard Deviation 7.33 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP, Day 1, 2 hours, n=16,16, 13,16 | -1.4 Millimeters of mercury | Standard Deviation 13.46 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 2, 24 hours, n=16,16, 13,16 | -2.7 Millimeters of mercury | Standard Deviation 9.76 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP, Day 1, 2 hours, n=16,16, 13,16 | 4.3 Millimeters of mercury | Standard Deviation 10.7 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 1, 12 hours, n=16,16, 13,16 | -3.6 Millimeters of mercury | Standard Deviation 9.87 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP, Day 1, 2 hours, n=16,16, 13,16 | 3.0 Millimeters of mercury | Standard Deviation 8.12 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 2, 24 hours, n=16,16, 13,16 | 0.7 Millimeters of mercury | Standard Deviation 7.6 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 1, 12 hours, n=15,16, 13,16 | -2.5 Millimeters of mercury | Standard Deviation 14.27 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | DBP,Day 2, 24 hours, n=16,16, 13,16 | -1.7 Millimeters of mercury | Standard Deviation 7.79 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | SBP,Day 1, 12 hours, n=15,16, 13,16 | -6.2 Millimeters of mercury | Standard Deviation 12.34 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | DBP, Day 1, 2 hours, n=16,16, 13,16 | -1.8 Millimeters of mercury | Standard Deviation 7.81 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | SBP,Day 2, 24 hours, n=16,16, 13,16 | -6.2 Millimeters of mercury | Standard Deviation 11.22 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | SBP, Day 1, 2 hours, n=16,16, 13,16 | -0.2 Millimeters of mercury | Standard Deviation 16.53 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part A | DBP,Day 1, 12 hours, n=16,16, 13,16 | -3.0 Millimeters of mercury | Standard Deviation 9.27 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 2, 24 hours, n=16,16, 13,16 | -1.1 Millimeters of mercury | Standard Deviation 8.82 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP, Day 1, 2 hours, n=16,16, 13,16 | -6.2 Millimeters of mercury | Standard Deviation 11.2 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 1, 12 hours, n=15,16, 13,16 | -2.9 Millimeters of mercury | Standard Deviation 18.7 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | SBP,Day 2, 24 hours, n=16,16, 13,16 | -3.9 Millimeters of mercury | Standard Deviation 14.11 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP, Day 1, 2 hours, n=16,16, 13,16 | -4.4 Millimeters of mercury | Standard Deviation 8.94 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part A | DBP,Day 1, 12 hours, n=16,16, 13,16 | -3.9 Millimeters of mercury | Standard Deviation 9.02 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, Pre-dose | 2.6 Millimeters of mercury | Standard Deviation 8.57 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 12 hours | 2.4 Millimeters of mercury | Standard Deviation 11.55 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 2, Pre-dose | -0.1 Millimeters of mercury | Standard Deviation 5.26 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 2, Pre-dose | -1.5 Millimeters of mercury | Standard Deviation 4.55 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 4, 24 hours | 2.9 Millimeters of mercury | Standard Deviation 9.22 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 1, 12 hours | 2.7 Millimeters of mercury | Standard Deviation 7.75 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 1, 12 hours | -1.7 Millimeters of mercury | Standard Deviation 5.5 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP, Day 1, 2 hours | 2.4 Millimeters of mercury | Standard Deviation 7.31 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 2 hours | 3.1 Millimeters of mercury | Standard Deviation 7 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, Pre-dose | -1.0 Millimeters of mercury | Standard Deviation 9.35 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 4, 24 hours | 3.0 Millimeters of mercury | Standard Deviation 5.56 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP, Day 1, 2 hours | -0.5 Millimeters of mercury | Standard Deviation 7.4 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 2 hours | 2.0 Millimeters of mercury | Standard Deviation 8.37 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 12 hours | -1.4 Millimeters of mercury | Standard Deviation 7.78 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, Pre-dose | 1.3 Millimeters of mercury | Standard Deviation 6.65 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP, Day 1, 2 hours | 5.4 Millimeters of mercury | Standard Deviation 7.37 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 1, 12 hours | 1.5 Millimeters of mercury | Standard Deviation 8.86 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 2, Pre-dose | 3.5 Millimeters of mercury | Standard Deviation 7.76 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, Pre-dose | 1.1 Millimeters of mercury | Standard Deviation 5.09 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 2 hours | 5.5 Millimeters of mercury | Standard Deviation 9.51 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 12 hours | 7.4 Millimeters of mercury | Standard Deviation 14.17 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | SBP,Day 4, 24 hours | 6.1 Millimeters of mercury | Standard Deviation 5.04 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP, Day 1, 2 hours | 2.1 Millimeters of mercury | Standard Deviation 7.16 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 1, 12 hours | -2.2 Millimeters of mercury | Standard Deviation 4.59 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 2, Pre-dose | 2.0 Millimeters of mercury | Standard Deviation 7.47 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 2 hours | 4.0 Millimeters of mercury | Standard Deviation 5.31 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 12 hours | -1.4 Millimeters of mercury | Standard Deviation 5.72 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part B | DBP,Day 4, 24 hours | 4.6 Millimeters of mercury | Standard Deviation 4.77 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 12 hours | -2.5 Millimeters of mercury | Standard Deviation 2.81 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 2, Pre-dose | -2.7 Millimeters of mercury | Standard Deviation 6.56 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 2 hours | -3.3 Millimeters of mercury | Standard Deviation 9.14 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, Pre-dose | -0.7 Millimeters of mercury | Standard Deviation 14.09 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, Pre-dose | 1.3 Millimeters of mercury | Standard Deviation 4.5 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 2, Pre-dose | 1.8 Millimeters of mercury | Standard Deviation 6.62 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP, Day 1, 2 hours | 1.2 Millimeters of mercury | Standard Deviation 7.08 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 3, 2 hours | -5.8 Millimeters of mercury | Standard Deviation 3.87 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 1, 12 hours | 1.0 Millimeters of mercury | Standard Deviation 10.73 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP, Day 1, 2 hours | -4.0 Millimeters of mercury | Standard Deviation 4.2 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 4, 24 hours | 6.0 Millimeters of mercury | Standard Deviation 11.24 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 4, 24 hours | 1.3 Millimeters of mercury | Standard Deviation 6.65 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | DBP,Day 1, 12 hours | -5.7 Millimeters of mercury | Standard Deviation 4.03 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part B | SBP,Day 3, 12 hours | 3.8 Millimeters of mercury | Standard Deviation 8.21 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | -3.3 Millimeters of mercury | Standard Deviation 7.93 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | -3.1 Millimeters of mercury | Standard Deviation 10.04 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | 4.9 Millimeters of mercury | Standard Deviation 8.02 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | -0.1 Millimeters of mercury | Standard Deviation 7.41 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | -2.1 Millimeters of mercury | Standard Deviation 7.23 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | 0.4 Millimeters of mercury | Standard Deviation 7.21 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | -2.6 Millimeters of mercury | Standard Deviation 8.34 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | -0.7 Millimeters of mercury | Standard Deviation 6.43 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | 1.0 Millimeters of mercury | Standard Deviation 4.88 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | -0.6 Millimeters of mercury | Standard Deviation 7.5 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | -1.4 Millimeters of mercury | Standard Deviation 6.71 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | -1.1 Millimeters of mercury | Standard Deviation 6.36 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | -0.5 Millimeters of mercury | Standard Deviation 6.64 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | -3.1 Millimeters of mercury | Standard Deviation 6.53 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | 2.0 Millimeters of mercury | Standard Deviation 6.92 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | -1.6 Millimeters of mercury | Standard Deviation 8.39 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | -0.6 Millimeters of mercury | Standard Deviation 6.16 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | 1.4 Millimeters of mercury | Standard Deviation 12.06 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | -4.3 Millimeters of mercury | Standard Deviation 6.94 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | 0.1 Millimeters of mercury | Standard Deviation 10.81 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | -3.1 Millimeters of mercury | Standard Deviation 8.5 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | 2.8 Millimeters of mercury | Standard Deviation 6.37 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | -0.6 Millimeters of mercury | Standard Deviation 8.02 |
| Part A: IR 120mg Fasted | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | -4.9 Millimeters of mercury | Standard Deviation 9.18 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | 1.1 Millimeters of mercury | Standard Deviation 16.02 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | -3.7 Millimeters of mercury | Standard Deviation 9.61 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | -7.3 Millimeters of mercury | Standard Deviation 14.92 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | 2.6 Millimeters of mercury | Standard Deviation 10.84 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | -0.6 Millimeters of mercury | Standard Deviation 7.88 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | 0.7 Millimeters of mercury | Standard Deviation 7.49 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | DBP, Day 1, 2 hours | -1.9 Millimeters of mercury | Standard Deviation 5.5 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | SBP,Day2, 24 hours | -7.5 Millimeters of mercury | Standard Deviation 10.58 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | DBP,Day1, 12 hours | 0.0 Millimeters of mercury | Standard Deviation 8.38 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | DBP,Day2, 24 hours | 2.4 Millimeters of mercury | Standard Deviation 6.21 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | SBP,Day1, 12 hours | 0.9 Millimeters of mercury | Standard Deviation 16.03 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Blood Pressure: Part C | SBP, Day 1, 2 hours | -0.2 Millimeters of mercury | Standard Deviation 11.44 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 2 hours | 0.02 Degree Celsius | Standard Deviation 0.152 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 2, 24 hours | 0.04 Degree Celsius | Standard Deviation 0.182 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 12 hours | 0.07 Degree Celsius | Standard Deviation 0.139 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 2 hours | 0.18 Degree Celsius | Standard Deviation 0.18 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 2, 24 hours | 0.07 Degree Celsius | Standard Deviation 0.095 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 12 hours | -0.04 Degree Celsius | Standard Deviation 0.145 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part A | Day 1, 12 hours | 0.13 Degree Celsius | Standard Deviation 0.118 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part A | Day 1, 2 hours | 0.05 Degree Celsius | Standard Deviation 0.145 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part A | Day 2, 24 hours | 0.12 Degree Celsius | Standard Deviation 0.114 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 2 hours | 0.14 Degree Celsius | Standard Deviation 0.126 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 2, 24 hours | 0.12 Degree Celsius | Standard Deviation 0.161 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part A | Day 1, 12 hours | 0.11 Degree Celsius | Standard Deviation 0.173 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 1, 12 hours | 0.06 Degree Celsius | Standard Deviation 0.181 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, 2 hours | -0.03 Degree Celsius | Standard Deviation 0.149 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, Pre-dose | 0.04 Degree Celsius | Standard Deviation 0.135 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 1, 2 hours | 0.03 Degree Celsius | Standard Deviation 0.298 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 4, 24 hours | 0.04 Degree Celsius | Standard Deviation 0.171 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, 12 hours | 0.01 Degree Celsius | Standard Deviation 0.191 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 2, Pre-dose | 0.04 Degree Celsius | Standard Deviation 0.184 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, Pre-dose | 0.07 Degree Celsius | Standard Deviation 0.271 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 1, 2 hours | -0.01 Degree Celsius | Standard Deviation 0.233 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 1, 12 hours | 0.08 Degree Celsius | Standard Deviation 0.274 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 2, Pre-dose | -0.04 Degree Celsius | Standard Deviation 0.158 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, 2 hours | 0.01 Degree Celsius | Standard Deviation 0.26 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 3, 12 hours | 0.05 Degree Celsius | Standard Deviation 0.242 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part B | Day 4, 24 hours | 0.11 Degree Celsius | Standard Deviation 0.247 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 3, 2 hours | -0.08 Degree Celsius | Standard Deviation 0.147 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 1, 12 hours | 0.07 Degree Celsius | Standard Deviation 0.082 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 4, 24 hours | 0.00 Degree Celsius | Standard Deviation 0.089 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 3, 12 hours | 0.05 Degree Celsius | Standard Deviation 0.138 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 3, Pre-dose | 0.23 Degree Celsius | Standard Deviation 0.151 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 2, Pre-dose | 0.12 Degree Celsius | Standard Deviation 0.133 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part B | Day 1, 2 hours | 0.00 Degree Celsius | Standard Deviation 0.11 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | 0.02 Degree Celsius | Standard Deviation 0.197 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | -0.10 Degree Celsius | Standard Deviation 0.245 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | -0.04 Degree Celsius | Standard Deviation 0.256 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | -0.11 Degree Celsius | Standard Deviation 0.229 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | -0.05 Degree Celsius | Standard Deviation 0.192 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | 0.15 Degree Celsius | Standard Deviation 0.261 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | -0.00 Degree Celsius | Standard Deviation 0.239 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | -0.07 Degree Celsius | Standard Deviation 0.215 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | -0.05 Degree Celsius | Standard Deviation 0.271 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | 0.12 Degree Celsius | Standard Deviation 0.307 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | 0.23 Degree Celsius | Standard Deviation 0.275 |
| Part A: IR 120mg Fasted | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | 0.10 Degree Celsius | Standard Deviation 0.278 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | -0.14 Degree Celsius | Standard Deviation 0.241 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | 0.01 Degree Celsius | Standard Deviation 0.228 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | -0.09 Degree Celsius | Standard Deviation 0.269 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Body Temperature: Part C | Day 2, 24 hours | -0.01 Degree Celsius | Standard Deviation 0.241 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Body Temperature: Part C | Day 1, 12 hours | -0.10 Degree Celsius | Standard Deviation 0.266 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Body Temperature: Part C | Day 1, 2 hours | 0.10 Degree Celsius | Standard Deviation 0.301 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 2 hours | -4.4 Beats per minute | Standard Deviation 5.11 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 2, 24 hours | 1.5 Beats per minute | Standard Deviation 9.41 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 12 hours | 4.8 Beats per minute | Standard Deviation 6.06 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 2 hours | -0.3 Beats per minute | Standard Deviation 4.88 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 2, 24 hours | -2.1 Beats per minute | Standard Deviation 6.31 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 12 hours | 5.2 Beats per minute | Standard Deviation 3.94 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part A | Day 1, 12 hours | 5.8 Beats per minute | Standard Deviation 5.57 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part A | Day 1, 2 hours | -2.5 Beats per minute | Standard Deviation 7.62 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part A | Day 2, 24 hours | 0.6 Beats per minute | Standard Deviation 7.14 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 2 hours | 3.9 Beats per minute | Standard Deviation 7.48 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 2, 24 hours | 0.9 Beats per minute | Standard Deviation 7.62 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part A | Day 1, 12 hours | 7.5 Beats per minute | Standard Deviation 9.93 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 1, 12 hours | 10.0 Beats per minute | Standard Deviation 4 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, 2 hours | 1.2 Beats per minute | Standard Deviation 5.37 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, Pre-dose | 2.3 Beats per minute | Standard Deviation 4.74 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 1, 2 hours | 0.0 Beats per minute | Standard Deviation 5.5 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 4, 24 hours | 4.7 Beats per minute | Standard Deviation 8.64 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, 12 hours | 8.6 Beats per minute | Standard Deviation 4.58 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 2, Pre-dose | -0.1 Beats per minute | Standard Deviation 4.68 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, Pre-dose | -0.1 Beats per minute | Standard Deviation 5.88 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 1, 2 hours | -2.4 Beats per minute | Standard Deviation 5.38 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 1, 12 hours | 8.8 Beats per minute | Standard Deviation 5.22 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 2, Pre-dose | -0.8 Beats per minute | Standard Deviation 6.37 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, 2 hours | -0.3 Beats per minute | Standard Deviation 5.36 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 3, 12 hours | 10.6 Beats per minute | Standard Deviation 7.26 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part B | Day 4, 24 hours | 6.7 Beats per minute | Standard Deviation 10.01 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 3, 2 hours | 4.0 Beats per minute | Standard Deviation 2.28 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 1, 12 hours | 10.5 Beats per minute | Standard Deviation 3.78 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 4, 24 hours | 0.3 Beats per minute | Standard Deviation 2.58 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 3, 12 hours | 7.7 Beats per minute | Standard Deviation 5.28 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 3, Pre-dose | 1.5 Beats per minute | Standard Deviation 5.43 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 2, Pre-dose | -1.8 Beats per minute | Standard Deviation 2.71 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part B | Day 1, 2 hours | 7.3 Beats per minute | Standard Deviation 6.89 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 6.8 Beats per minute | Standard Deviation 6.2 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | 2.1 Beats per minute | Standard Deviation 6.94 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | 1.8 Beats per minute | Standard Deviation 5.44 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 6.5 Beats per minute | Standard Deviation 9.73 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | -5.3 Beats per minute | Standard Deviation 6.19 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | 0.1 Beats per minute | Standard Deviation 6.41 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 11.2 Beats per minute | Standard Deviation 9.65 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | 0.0 Beats per minute | Standard Deviation 6.86 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | -0.4 Beats per minute | Standard Deviation 3.77 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 10.3 Beats per minute | Standard Deviation 6.94 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | 7.3 Beats per minute | Standard Deviation 6.56 |
| Part A: IR 120mg Fasted | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | 0.4 Beats per minute | Standard Deviation 5.8 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 9.3 Beats per minute | Standard Deviation 8.28 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | 8.2 Beats per minute | Standard Deviation 5.72 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | -0.9 Beats per minute | Standard Deviation 6.19 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Heart Rate: Part C | Day 1, 2 hours | 8.2 Beats per minute | Standard Deviation 7.32 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Heart Rate: Part C | Day 2, 24 hours | 1.6 Beats per minute | Standard Deviation 7.74 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Heart Rate: Part C | Day 1, 12 hours | 8.6 Beats per minute | Standard Deviation 6.99 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 2 hours | -0.4 Breaths per minute | Standard Deviation 1.67 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 2, 24 hours | 1.3 Breaths per minute | Standard Deviation 2.15 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 12 hours | -0.6 Breaths per minute | Standard Deviation 1.71 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 2 hours | 0.8 Breaths per minute | Standard Deviation 1.65 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 2, 24 hours | -0.1 Breaths per minute | Standard Deviation 1.54 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 12 hours | -0.1 Breaths per minute | Standard Deviation 1.82 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part A | Day 1, 12 hours | -0.2 Breaths per minute | Standard Deviation 1.21 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part A | Day 1, 2 hours | 0.0 Breaths per minute | Standard Deviation 1 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part A | Day 2, 24 hours | -1.5 Breaths per minute | Standard Deviation 1.51 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 2 hours | -1.5 Breaths per minute | Standard Deviation 2.5 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 2, 24 hours | -1.4 Breaths per minute | Standard Deviation 2.13 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part A | Day 1, 12 hours | -2.4 Breaths per minute | Standard Deviation 2.63 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 1, 12 hours | -0.1 Breaths per minute | Standard Deviation 1.37 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, 2 hours | -1.3 Breaths per minute | Standard Deviation 2.36 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, Pre-dose | -0.7 Breaths per minute | Standard Deviation 2.67 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 1, 2 hours | 0.5 Breaths per minute | Standard Deviation 2.27 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 4, 24 hours | -0.8 Breaths per minute | Standard Deviation 1.87 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, 12 hours | 0.3 Breaths per minute | Standard Deviation 3.02 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 2, Pre-dose | -0.3 Breaths per minute | Standard Deviation 1.49 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, Pre-dose | -0.5 Breaths per minute | Standard Deviation 1.43 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 1, 2 hours | -2.0 Breaths per minute | Standard Deviation 2 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 1, 12 hours | -2.5 Breaths per minute | Standard Deviation 2.17 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 2, Pre-dose | -0.5 Breaths per minute | Standard Deviation 2.07 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, 2 hours | -1.0 Breaths per minute | Standard Deviation 2.21 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 3, 12 hours | -1.3 Breaths per minute | Standard Deviation 2.16 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part B | Day 4, 24 hours | -1.0 Breaths per minute | Standard Deviation 1.89 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 3, 2 hours | -0.7 Breaths per minute | Standard Deviation 2.16 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 1, 12 hours | -1.5 Breaths per minute | Standard Deviation 2.35 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 4, 24 hours | -0.3 Breaths per minute | Standard Deviation 2.42 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 3, 12 hours | -0.8 Breaths per minute | Standard Deviation 1.33 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 3, Pre-dose | 1.5 Breaths per minute | Standard Deviation 2.26 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 2, Pre-dose | -0.5 Breaths per minute | Standard Deviation 2.74 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part B | Day 1, 2 hours | -1.2 Breaths per minute | Standard Deviation 3.54 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | 1.1 Breaths per minute | Standard Deviation 2.59 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | 1.7 Breaths per minute | Standard Deviation 3.37 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | 1.6 Breaths per minute | Standard Deviation 3.25 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | 1.0 Breaths per minute | Standard Deviation 2.85 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | 0.6 Breaths per minute | Standard Deviation 2.03 |
| Part A: MT-8hour 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | 0.4 Breaths per minute | Standard Deviation 3.07 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | 0.6 Breaths per minute | Standard Deviation 2.66 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | 0.9 Breaths per minute | Standard Deviation 2.9 |
| Part A: MT-12hour 120mg Fed (High Fat) | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | 0.6 Breaths per minute | Standard Deviation 4 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | -1.1 Breaths per minute | Standard Deviation 2.9 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | -1.1 Breaths per minute | Standard Deviation 2.95 |
| Part A: IR 120mg Fasted | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | -2.2 Breaths per minute | Standard Deviation 2.66 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | -0.3 Breaths per minute | Standard Deviation 2.61 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | 1.8 Breaths per minute | Standard Deviation 1.74 |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | 1.8 Breaths per minute | Standard Deviation 2.31 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Respiration Rate: Part C | Day 1, 2 hours | 0.1 Breaths per minute | Standard Deviation 2.76 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Respiration Rate: Part C | Day 2, 24 hours | 0.4 Breaths per minute | Standard Deviation 3.34 |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Change From Baseline in Respiration Rate: Part C | Day 1, 12 hours | 0.5 Breaths per minute | Standard Deviation 1.51 |
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: IR 120mg Fasted | Cmax of GSK2982772 After Meal in Part C | 1.547 Microgram/milliliter | Geometric Coefficient of Variation 40.8 |
| Part A: MT-8hour 120mg Fasted | Cmax of GSK2982772 After Meal in Part C | 1.064 Microgram/milliliter | Geometric Coefficient of Variation 62.6 |
| Part A: MT-12hour 120mg Fed (High Fat) | Cmax of GSK2982772 After Meal in Part C | 3.151 Microgram/milliliter | Geometric Coefficient of Variation 32.5 |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: IR 120mg Fasted | Cmax of GSK2982772 in Part B | Day 1 | 0.417 Microgram/milliliter | Geometric Coefficient of Variation 25.5 |
| Part A: IR 120mg Fasted | Cmax of GSK2982772 in Part B | Day 3 | 0.398 Microgram/milliliter | Geometric Coefficient of Variation 32.9 |
| Part A: MT-8hour 120mg Fasted | Cmax of GSK2982772 in Part B | Day 1 | 0.707 Microgram/milliliter | Geometric Coefficient of Variation 44.7 |
| Part A: MT-8hour 120mg Fasted | Cmax of GSK2982772 in Part B | Day 3 | 0.794 Microgram/milliliter | Geometric Coefficient of Variation 35.7 |
| Part A: MT-12hour 120mg Fed (High Fat) | Cmax of GSK2982772 in Part B | Day 1 | 0.888 Microgram/milliliter | Geometric Coefficient of Variation 14.1 |
| Part A: MT-12hour 120mg Fed (High Fat) | Cmax of GSK2982772 in Part B | Day 3 | 1.080 Microgram/milliliter | Geometric Coefficient of Variation 40.4 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A | 123.64 Percentage bioavailability |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C | 94.69 Percentage bioavailability |
| Part A: MT-8hour 120mg Fasted | Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C | 113.51 Percentage bioavailability |
| Part A: MT-12hour 120mg Fed (High Fat) | Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C | 91.13 Percentage bioavailability |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A | 225.07 Percentage bioavailability |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: IR 120mg Fasted | Frelformulation Based on Cmax of GSK2982772 After Meal in Part C | 76.56 Percentage bioavailability |
| Part A: MT-8hour 120mg Fasted | Frelformulation Based on Cmax of GSK2982772 After Meal in Part C | 156.77 Percentage bioavailability |
| Part A: MT-12hour 120mg Fed (High Fat) | Frelformulation Based on Cmax of GSK2982772 After Meal in Part C | 113.81 Percentage bioavailability |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part B | Abnormal, not clinically significant | 4 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part B | Abnormal, clinically significant | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal ECG Findings: Part B | Abnormal, not clinically significant | 4 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal ECG Findings: Part B | Abnormal, clinically significant | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal ECG Findings: Part B | Abnormal, not clinically significant | 2 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal ECG Findings: Part B | Abnormal, clinically significant | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 4 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 7 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 5 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 6 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, not clinically significant | 3 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants Abnormal ECG Findings: Part C | Abnormal, clinically significant | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, not clinically significant | 6 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, clinically significant | 1 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, clinically significant | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, not clinically significant | 8 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, not clinically significant | 9 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, clinically significant | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, not clinically significant | 9 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A | Abnormal, clinically significant | 0 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part A | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part A | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal Urinalysis Dipstick Results: Part A | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part A | 0 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part B | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part B | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal Urinalysis Dipstick Results: Part B | 0 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants Abnormal Urinalysis Dipstick Results: Part C | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any AEs | 4 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any SAEs | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any SAEs | 1 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any AEs | 5 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any AEs | 1 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any SAEs | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any AEs | 2 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A | Any SAEs | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part B | Any AEs | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part B | Any SAEs | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With AE and SAE in Part B | Any AEs | 3 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With AE and SAE in Part B | Any SAEs | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With AE and SAE in Part B | Any AEs | 1 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With AE and SAE in Part B | Any SAEs | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part C | Any AEs | 3 Participants |
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With AE and SAE in Part C | Any AEs | 3 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With AE and SAE in Part C | Any AEs | 3 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part C | Any AEs | 4 Participants |
| Part A: IR 120mg Fasted | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With AE and SAE in Part C | Any AEs | 2 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With AE and SAE in Part C | Any AEs | 1 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With AE and SAE in Part C | Any SAEs | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, normal or no change16 | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, high | 1 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, normal or no change16 | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, normal or no change16 | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, high | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, normal or no change16 | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Sodium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Total Bilirubin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Albumin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | AST, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALP, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | ALT, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Creatinine, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Glucose, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Potassium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A | Calcium, high | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, normal or no change | 10 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Total Bilirubin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Calcium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Glucose, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Albumin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Sodium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Potassium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALP, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | Creatinine, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | AST, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B | ALT, low | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 15 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 15 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 1 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 14 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, high | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Glucose, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALT, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Calcium, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Total Bilirubin, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Creatinine, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Potassium, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | AST, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Albumin, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | ALP, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C | Sodium, low | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, low | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, low | 1 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, normal or no change | 16 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, normal or no change | 13 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, low | 2 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, normal or no change | 11 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, low | 1 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, normal or no change | 12 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Platelet count, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hematocrit, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Total Neutrophils, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | WBC, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Lymphocytes, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A | Hemoglobin, high | 0 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, normal or no change | 10 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, normal or no change | 10 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Lymphocytes, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Platelet count, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hematocrit, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Hemoglobin, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | Total Neutrophils, normal or no change | 6 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B | WBC, normal or no change | 6 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 15 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 15 Participants |
| Part A: MT-8hour 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 16 Participants |
| Part A: MT-12hour 120mg Fed (High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 16 Participants |
| Part A: IR 120mg Fasted | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 15 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part C:MM-12h 480mg Delayed Fed(Standard) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | WBC, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, normal or no change | 14 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hemoglobin, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Hematocrit, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Lymphocytes, low | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Platelet count, high | 0 Participants |
| Part C: MM-12h 240mg Delayed Fed(High Fat) | Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C | Total Neutrophils, high | 0 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: IR 120mg Fasted | Tmax of GSK2982772 After Meal in Part C | 4.000 Hours |
| Part A: MT-8hour 120mg Fasted | Tmax of GSK2982772 After Meal in Part C | 4.000 Hours |
| Part A: MT-12hour 120mg Fed (High Fat) | Tmax of GSK2982772 After Meal in Part C | 5.017 Hours |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: IR 120mg Fasted | Tmax of GSK2982772 in Part B | Day 1 | 4.058 Hours |
| Part A: IR 120mg Fasted | Tmax of GSK2982772 in Part B | Day 3 | 4.000 Hours |
| Part A: MT-8hour 120mg Fasted | Tmax of GSK2982772 in Part B | Day 1 | 4.067 Hours |
| Part A: MT-8hour 120mg Fasted | Tmax of GSK2982772 in Part B | Day 3 | 5.025 Hours |
| Part A: MT-12hour 120mg Fed (High Fat) | Tmax of GSK2982772 in Part B | Day 1 | 4.000 Hours |
| Part A: MT-12hour 120mg Fed (High Fat) | Tmax of GSK2982772 in Part B | Day 3 | 4.000 Hours |