A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772

A Two Part, Non-randomised, Open Label Study Designed to Assess the Pharmacokinetic Profile of Modified Release Prototype Coated Tablet Formulations of GSK2982772 Relative to an Immediate Release Reference Tablet Formulation at a Fixed Strength (Part A) and the Pharmacokinetic Profile of Alternative Tablet Strengths of the Selected Modified Release Prototype Coated Tablet Formulation (Part B, Optional) in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03649412

Enrollment

Registered

2018-08-28

Start date

2018-09-26

Completion date

2019-05-07

Last updated

2020-05-01

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

Conditions

Autoimmune Diseases

Keywords

Tablet formulation, Sequence, Immediate release, Pharmacokinetic

Brief summary

Previous clinical studies of immediate release (IR) formulations of GSK2982772 resulted in a high peak to trough ratio of GSK2982772. Additionally, the short half-life for GSK2982772 (approximately 2 to 3 hours) necessitates twice a daily (BID) or thrice daily (TID) dosing of an IR formulation. As a result, MR formulations using a polymer matrix approach with minitablets in capsule and MR tablet formulations were investigated. The emerging PK data of the MR formulations investigated to date have demonstrated that a once daily (QD) PK profile can be achieved in the fasted state but the polymer matrix formulation is susceptible to food effects when administered with a high fat breakfast. The purpose of this study is to evaluate MR prototype coated tablet formulations. This study will evaluate the PK of MR prototype coated tablet formulations of GSK2982772. The study is divided into two parts; Part A and Part B. The MR tablet coating used in Part A and the initial periods of Part B will have an aperture drilled into the enteric coating of either side of the tablet. This allows some drug release to commence in the stomach whilst providing controlled release throughout the gastrointestinal (GI) tract. In Part B only, a new investigational medicinal product (IMP) will be manufactured to allow comparison of the tablet coating either with apertures (i.e., drilled) or without apertures (i.e., full coat/non drilled). Part A will be a 6-period, 6-way fixed sequence design, up to 4 MR tablet prototype coated formulations will be evaluated in fasted state at 240 milligrams (mg). Periods 1, 2 and 3 will evaluate MR1, IR tablet and MR2 respectively. Periods 4, 5 and 6 will be flexible and the dosing regimen will be dependent on the outcome of Periods 1 to 3. In addition, the impact of food (high fat meal, standard breakfast or administration 30 or 60 minutes before a standard breakfast) on selected MR prototype coated tablet formulations may also be evaluated in Period 4, 5 or 6 of Part A. Each inpatient period for MR regimens (Periods 1, 3, 4 to 6) will consist of 4 days and 3 nights, and the inpatient period for the IR tablet (Period 2) will consist of 3 days and 2 nights. There will be a minimum washout of 7 days between doses, and a follow-up visit will occur at 7 to 9 days after the last study treatment. The Part B of the study will be a 7-period fixed sequence which will evaluate the selected MR prototype coated tablet formulation(s) at different tablet strengths or as multiple unit doses and with or without apertures in the tablet coatings. There will be an interim review after each period 1 to 5 of Part B to select the dose level, formulation and prandial status for each subsequent period. An interim data review after Part B Period 6 will determine if optional Period 7 is required and the dose level, dosing time (morning or evening), formulation and prandial status for that period. Each inpatient period will consist of a 4-day and 3-night with a minimum of 7 days washout between doses. A follow-up visit will occur at 7 to 9 days after the last study treatment. Approximately 33 subjects will be enrolled in the study. The total duration for Part A will be approximately 10-12 weeks and 10-14 weeks for Part B (including screening period of approximately 4 weeks).

Interventions

DRUGGSK2982772 Modified Release

GSK2982772 MR will be available as MR prototype coated tablet with unit dose strength of 240 mg in Part A. In Part B, GSK2982772 MR prototype coated tablet with unit dose strength of 120 mg (may be changed following interim review of Part B) will be administered by subjects. GSK2982772 MR will be administered orally with 240 milliliter (mL) of water.

DRUGGSK2982772 Immediate Release

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 240 mg (8 tablets of dose strength 30 mg) orally with 240 mL of water

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

There will be no masking as this is an open-label study.

Intervention model description

Part A will be a 6-period, 6-way fixed sequence design, in which up to 4 MR tablet prototype coated formulation will be evaluated, following single dose administration (240 mg) in fasted or fed state. There will be a minimum 7-day washout between doses. Part B of the study is optional. Following the final period of Part A, there will be an interim review to determine whether to proceed with optional Part B, and if so, the formulations and tablet strengths to be investigated in Part B. The Part B of the study will be a 7-period fixed sequence which will evaluate the selected MR prototype coated tablet formulation(s) at different tablet strengths or as multiple unit doses.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject at the time of participation must be 18 to 65 years of age. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body weight greater than or equal to 50 kilogram (kg) and body mass index within the range 19.0 to 32.0 kg per squared meter (kg/m\^2) (inclusive). * Male or female subjects where male subjects are eligible to participate if they agree to the following during the intervention period until completion of the final follow up visit after the last dose of study treatment; refrain from sperm donation; plus either be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception/barrier like use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant; agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person. * The eligible female subjects can participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency, for at least 30 days before first dose until completion of the final follow up visit after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction from Day 1 until 3 months after the last dose. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention; a WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention; additional requirements for pregnancy testing during and after study intervention must be followed; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Capable of giving an 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. * Any history of suicidal behavior within the past 6 months or any history of attempted suicide in subject's lifetime. * 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. Hayfever is allowed unless it is active. * Alanine transaminase (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 (QTcF) greater than 450 milliseconds (msec). * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 gram per day\], 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 plus 5 half lives, of the last dose of study medication. * Participation in the study would result in loss of blood or blood products in excess of 500 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. * Current or history of renal disease or estimated glomerular filtration rate by chronic kidney disease epidemiology collaboration (CKD-EPI) equation calculation less than 60 milliliter (mL) per minute per 1.73 m\^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. * 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 than14 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer or 1 (25 mL) measure of spirits, 1.5 to 2 units is 1 glass (125 mL) of wine, depending on type. * 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. * Subjects who do not have suitable veins for multiple venipuncture's/cannulation as assessed by the investigator at screening. * Total cholesterol greater than or equal to 300 mg per deciliter (mg/dL) (greater than or equal to 7.77 millimole 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 or sponsor employees, or immediate family members of a study site or sponsor employee.

Design outcomes

Primary

Measure	Time frame	Description
Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours	Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 in fasted state. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fasted formulation (test) / Geometric mean of Cmax of Fasted Formulation of IR formulation (reference) multiplied by 100.
Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR Fed/Geometric mean of AUC(0-t) of MR Fasted multiplied by 100.
Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fed/Geometric mean of Cmax of MR Fasted multiplied by 100.
Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on AUC(0-inf) of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on AUC (0-t) of GSK2982772. FrelFE for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MR Fed/ Geometric mean of AUC (0-t) of MR Fasted multiplied by 100.
Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. FrelFE for Cmax was calculated as Geometric mean of Cmax of MR Fed/ Geometric mean of Cmax of MR Fasted multiplied by 100.
Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC (0-inf) of GSK2982772. Frel (dose) for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MR formulation (test dose) Fasted/ Geometric mean of AUC (0-inf) of MR Fasted formulation (reference dose) multiplied by 100.
Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-t) of GSK2982772. Frel (dose) for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR formulation (test dose) Fasted/ Geometric mean of AUC(0-t) of MR Fasted formulation (reference dose) multiplied by 100.
Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State	Pre-dose, 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 Frel (dose) based on AUC(0-24) of GSK2982772. Frel (dose) for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR formulation (test dose) Fasted/Geometric mean of AUC(0-24) of MR Fasted formulation (reference dose) multiplied by 100.
Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of Frel dose. Frel for Cmax was calculated as Geometric mean of Cmax of MR formulation (test) Fasted/ Geometric mean of Cmax of MR Fasted Formulation (reference dose) multiplied by 100.
Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC(0-inf) of GSK2982772 in fasted state. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR formulation (test) Fasted/ Geometric mean of AUC(0-inf) of Fasted of IR Formulation (reference) multiplied by 100.
Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours	Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC (0-t) was calculated as Geometric mean of AUC(0-t) of MR Fasted formulation (test) / Geometric mean of AUC(0-t) of Fasted of IR Formulation (reference) multiplied by 100.
Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours	Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR Fasted formulation (test) / Geometric mean of AUC(0-24) of Fasted of IR Formulation (reference) multiplied by 100.
Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were analyzed using standard non-compartmental analysis. Participants in the 'Safety Population (all participants who received at least one dose of study treatment)' for whom a PK sample was obtained and analyzed were part of PK Population.
Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation	24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 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). PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 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). PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation	24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation	Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours	Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours	Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC(0-inf). PK parameters were analyzed using standard non-compartmental analysis.
Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for AUC(0-t). PK parameters were analyzed using standard non-compartmental analysis.
Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose post-dose	Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	24 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose	Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.

Secondary

Measure	Time frame	Description
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Up to Day 67	Clinical chemistry parameters with PCI values:albumin (low: \<30 millimoles per liter\[mmol/L\]), Alanine transaminase (ALT) (high: \>=2xupper limit of normal \[ULN\]), Aspartate Aminotransferase(AST) (high: \>=2xULN), Alkaline phosphatase(ALP) (high:\>=2xULN), calcium(low: \<2 mmol/L, high: \>2.75 mmol/L),creatinine (high: \>44.2 mmol/L),glucose (low: \<3 mmol/L,high: \>9 mmol/L), potassium (low: \<3 mmol/L,high: \>5.5 mmol/L),sodium (low: \<130 mmol/L,high: \>150 mmol/L),total bilirubin(high :\>= 1.5xULN). 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 participants has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Data for worst-case post-Baseline has been reported.
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Up to Day 67	Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\giga cells per liter \[10\^9/L\]), total neutrophil count (low: \<1.5\10\^9/L), platelet count (low: \<100\10\^9/L and high: \>550\10\^9/L), and while blood cell (WBC) count (low: \<3\10\^9/L and high: \>20\10\^9/L). 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%. Data for worst-case post-Baseline has been reported.
Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	Day 2 (post-dose)	Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed abnormal data for red blood cells (RBC): 1-9 High potential field (HPF) and WBC: 1-9/ HPF; WBC: 10-50/HPF has been presented.
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours	SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. 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.
Part A: Change From Baseline in SBP and DBP in MR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours	SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. 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.
Part A: Change From Baseline in Heart Rate in IR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours	Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. 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.
Part A: Change From Baseline in Heart Rate in MR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours	Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. 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.
Part A: Change From Baseline in Respiration Rate in IR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours	Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. 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.
Part A: Change From Baseline in Respiration Rate in MR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours	Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. 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.
Part A: Change From Baseline in Body Temperature in IR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 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.
Part A: Change From Baseline in Body Temperature in MR Formulation	Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 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.
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation	Up to Day 67	Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Up to Day 67	Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 67	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 that may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Countries

United Kingdom

Participant flow

Recruitment details

This was an open-label, 2-part (Part A & B), single dose study in healthy participants to assess modified release (MR) prototype coated tablet formulations of GSK2982772 compared to an immediate release reference tablet formulation.

Pre-assignment details

A total of 33 participants were enrolled in this study. In Part A, 16 participants were enrolled but 1 replacement participant was added (total=17). Participants from Part A did not continue to Part B. In Part B, 16 participants were enrolled.

Participants by arm

Arm	Count
MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent \[%\] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.	17
MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std) Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.	16
Total	33

Withdrawals & dropouts

Period	Reason	FG000	FG001
Part A, Washout Period 1 (7 Days)	Physician Decision	1	0
Part A, Washout Period 4 (7 Days)	Adverse Event	1	0
Part A, Washout Period 4 (7 Days)	Withdrawal by Subject	1	0
Part A, Washout Period 5 (7 Days)	Adverse Event	1	0
Part B, Washout Period 1 (7 Days)	Adverse Event	0	1
Part B, Washout Period 5 (7 Days)	Adverse Event	0	1

Baseline characteristics

Characteristic	MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)	Total	MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast
Age, Continuous	54.0 Years STANDARD_DEVIATION 6.3	48.6 Years STANDARD_DEVIATION 11.01	43.5 Years STANDARD_DEVIATION 12.17
Race/Ethnicity, Customized AFRICAN AMERICAN/AFRICAN HERITAGE	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized ARABIC/NORTH AFRICAN HERITAGE	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized CENTRAL/SOUTH ASIAN HERITAGE	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized MULTIPLE	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized WHITE/CAUCASIAN/EUROPEAN HERITAGE	13 Participants	29 Participants	16 Participants
Sex: Female, Male Female	6 Participants	13 Participants	7 Participants
Sex: Female, Male Male	10 Participants	20 Participants	10 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
deaths Total, all-cause mortality	0 / 16	0 / 16	0 / 16	0 / 12	0 / 16	0 / 12	0 / 16	0 / 14	0 / 15	0 / 14	0 / 15	0 / 15
other Total, other adverse events	2 / 16	5 / 16	3 / 16	3 / 12	3 / 16	4 / 12	8 / 16	4 / 14	1 / 15	3 / 14	3 / 15	3 / 15
serious Total, serious adverse events	0 / 16	0 / 16	0 / 16	0 / 12	0 / 16	0 / 12	0 / 16	0 / 14	0 / 15	0 / 14	0 / 15	0 / 15

Outcome results

Primary

Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation	14.268 Hours*microgram per milliliter	Geometric Coefficient of Variation 31.2

Primary

Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were analyzed using standard non-compartmental analysis. Participants in the 'Safety Population (all participants who received at least one dose of study treatment)' for whom a 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, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation	14.355 Hours*microgram per milliliter	Geometric Coefficient of Variation 31.1

Primary

Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation	14.269 Hours*microgram per milliliter	Geometric Coefficient of Variation 31.2

Primary

Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 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 240 mg Fasted	Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation	6.670 Hours*microgram per milliliter	Geometric Coefficient of Variation 24.9
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation	5.784 Hours*microgram per milliliter	Geometric Coefficient of Variation 31.8
Part A: MR-16h 240 mg Fasted	Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation	5.466 Hours*microgram per milliliter	Geometric Coefficient of Variation 33.1

Primary

Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 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 240 mg Fasted	Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	7.136 Hours*microgram per milliliter	Geometric Coefficient of Variation 33.5
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	5.821 Hours*microgram per milliliter	Geometric Coefficient of Variation 32.1

Primary

Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 240 mg Fasted	Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation	7.757 Hours*microgram per milliliter	Geometric Coefficient of Variation 19.1
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation	8.346 Hours*microgram per milliliter	Geometric Coefficient of Variation 27.7
Part A: MR-16h 240 mg Fasted	Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation	7.080 Hours*microgram per milliliter	Geometric Coefficient of Variation 46.8

Primary

Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 240 mg Fasted	Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast	9.372 Hours*microgram per milliliter	Geometric Coefficient of Variation 21.8
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast	8.220 Hours*microgram per milliliter	Geometric Coefficient of Variation 37.2

Primary

Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation	8.175 Hours*microgram per milliliter	Geometric Coefficient of Variation 23.9
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation	7.828 Hours*microgram per milliliter	Geometric Coefficient of Variation 28.5
Part A: MR-16h 240 mg Fasted	Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation	7.365 Hours*microgram per milliliter	Geometric Coefficient of Variation 36.4

Primary

Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	9.359 Hours*microgram per milliliter	Geometric Coefficient of Variation 23.1
Part A: MR-18h 240 mg Fasted	Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	8.384 Hours*microgram per milliliter	Geometric Coefficient of Variation 32.7

Primary

Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation	0.196 Microgram per milliliter	Geometric Coefficient of Variation 64.8
Part A: MR-18h 240 mg Fasted	Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation	0.211 Microgram per milliliter	Geometric Coefficient of Variation 63.1
Part A: MR-16h 240 mg Fasted	Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation	0.165 Microgram per milliliter	Geometric Coefficient of Variation 98.3

Primary

Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	0.213 Microgram per milliliter	Geometric Coefficient of Variation 70.4
Part A: MR-18h 240 mg Fasted	Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	0.265 Microgram per milliliter	Geometric Coefficient of Variation 85.5

Primary

Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation	0.682 Microgram per milliliter	Geometric Coefficient of Variation 39.4
Part A: MR-18h 240 mg Fasted	Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation	0.527 Microgram per milliliter	Geometric Coefficient of Variation 24.4
Part A: MR-16h 240 mg Fasted	Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation	0.466 Microgram per milliliter	Geometric Coefficient of Variation 27.5

Primary

Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	0.824 Microgram per milliliter	Geometric Coefficient of Variation 47.5
Part A: MR-18h 240 mg Fasted	Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	0.678 Microgram per milliliter	Geometric Coefficient of Variation 47

Primary

Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation	0.015 Microgram per milliliter	Geometric Coefficient of Variation 60.8

Primary

Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation

Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR Fed/Geometric mean of AUC(0-t) of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation	107.11 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation	107.81 Percentage bioavailability

Primary

Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation

Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fed/Geometric mean of Cmax of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation	128.79 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation	112.15 Percentage bioavailability

Primary

Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR Fasted formulation (test) / Geometric mean of AUC(0-24) of Fasted of IR Formulation (reference) multiplied by 100.

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

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	47.77 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	36.85 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	40.54 Percentage bioavailability

Primary

Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC (0-t) was calculated as Geometric mean of AUC(0-t) of MR Fasted formulation (test) / Geometric mean of AUC(0-t) of Fasted of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	57.72 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	49.61 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)	54.86 Percentage bioavailability

Primary

Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 in fasted state. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fasted formulation (test) / Geometric mean of Cmax of Fasted Formulation of IR formulation (reference) multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)	22.29 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)	14.16 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)	16.58 Percentage bioavailability

Primary

Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation	3.177 Microgram per milliliter	Geometric Coefficient of Variation 40.1

Primary

Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg

Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC(0-inf) of GSK2982772 in fasted state. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR formulation (test) Fasted/ Geometric mean of AUC(0-inf) of Fasted of IR Formulation (reference) multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg	54.68 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg	48.32 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg	57.69 Percentage bioavailability

Primary

Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation

Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

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

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation	102.66 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation	113.66 Percentage bioavailability

Primary

Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation	6.329 Hours	Standard Deviation 2.1447
Part A: MR-18h 240 mg Fasted	Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation	6.953 Hours	Standard Deviation 2.4983
Part A: MR-16h 240 mg Fasted	Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation	7.532 Hours	Standard Deviation 2.2685

Primary

Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	7.763 Hours	Standard Deviation 1.4693
Part A: MR-18h 240 mg Fasted	Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	6.589 Hours	Standard Deviation 1.0499

Primary

Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation	3.288 Hours	Standard Deviation 0.501

Primary

Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation

Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Part A: IR 240 mg Fasted	Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation	2.000 Hours

Primary

Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation

Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Part A: IR 240 mg Fasted	Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation	5.000 Hours
Part A: MR-18h 240 mg Fasted	Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation	10.000 Hours
Part A: MR-16h 240 mg Fasted	Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation	6.000 Hours

Primary

Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Part A: IR 240 mg Fasted	Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	8.000 Hours
Part A: MR-18h 240 mg Fasted	Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast	11.000 Hours

Primary

Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-inf). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 240 mg Fasted	Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	20.121 Hours*microgram per milliliter	Geometric Coefficient of Variation 46.2
Part A: MR-18h 240 mg Fasted	Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	20.178 Hours*microgram per milliliter	Geometric Coefficient of Variation 62.8

Primary

Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-t). PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	19.865 Hours*microgram per milliliter	Geometric Coefficient of Variation 39.7
Part A: MR-18h 240 mg Fasted	Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	17.861 Hours*microgram per milliliter	Geometric Coefficient of Variation 47.1

Primary

Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: 24 hours post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	0.622 Microgram per milliliter	Geometric Coefficient of Variation 132.9
Part A: MR-18h 240 mg Fasted	Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	1.176 Microgram per milliliter	Geometric Coefficient of Variation 80.6

Primary

Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose post-dose

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	1.896 Hours*microgram per milliliter	Geometric Coefficient of Variation 63.3
Part A: MR-18h 240 mg Fasted	Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	1.791 Hours*microgram per milliliter	Geometric Coefficient of Variation 75

Primary

Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State

Blood samples were collected at indicated time points for analysis of FrelFE based on AUC(0-inf) of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

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

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State	141.75 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State	97.13 Percentage bioavailability

Primary

Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State

Blood samples were collected at indicated time points for analysis of FrelFE based on AUC (0-t) of GSK2982772. FrelFE for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MR Fed/ Geometric mean of AUC (0-t) of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State	129.63 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State	89.77 Percentage bioavailability

Primary

Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State

Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. FrelFE for Cmax was calculated as Geometric mean of Cmax of MR Fed/ Geometric mean of Cmax of MR Fasted multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State	173.19 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State	102.39 Percentage bioavailability

Primary

Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State

Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-24) of GSK2982772. Frel (dose) for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR formulation (test dose) Fasted/Geometric mean of AUC(0-24) of MR Fasted formulation (reference dose) multiplied by 100.

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

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State	175.58 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State	392.65 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State	223.63 Percentage bioavailability

Primary

Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State

Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC (0-inf) of GSK2982772. Frel (dose) for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MR formulation (test dose) Fasted/ Geometric mean of AUC (0-inf) of MR Fasted formulation (reference dose) multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

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

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State	214.21 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State	530.86 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State	247.82 Percentage bioavailability

Primary

Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State

Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-t) of GSK2982772. Frel (dose) for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR formulation (test dose) Fasted/ Geometric mean of AUC(0-t) of MR Fasted formulation (reference dose) multiplied by 100.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State	192.81 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State	539.66 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State	279.90 Percentage bioavailability

Primary

Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State

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

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (NUMBER)
Part A: IR 240 mg Fasted	Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State	160.00 Percentage bioavailability
Part A: MR-18h 240 mg Fasted	Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State	338.70 Percentage bioavailability
Part A: MR-16h 240 mg Fasted	Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State	211.68 Percentage bioavailability

Primary

Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

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

Arm	Measure	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	4.961 Hours	Standard Deviation 1.0921
Part A: MR-18h 240 mg Fasted	Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	4.873 Hours	Standard Deviation 1.9915

Primary

Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Part A: IR 240 mg Fasted	Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	12.000 Hours
Part A: MR-18h 240 mg Fasted	Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast	22.008 Hours

Secondary

Part A: Change From Baseline in Body Temperature in IR Formulation

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: 24 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in IR Formulation	Day 1, 2 hours	0.04 Degrees Celsius	Standard Deviation 0.159
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in IR Formulation	Day 1, 12 hours	0.13 Degrees Celsius	Standard Deviation 0.241
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in IR Formulation	Day 2, 24 hours	0.10 Degrees Celsius	Standard Deviation 0.183

Secondary

Part A: Change From Baseline in Body Temperature in MR Formulation

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 2, 24 hours	-0.03 Degrees Celsius	Standard Deviation 0.188
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 2 hours	-0.04 Degrees Celsius	Standard Deviation 0.216
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 12 hours	0.12 Degrees Celsius	Standard Deviation 0.18
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 3, 48 hours	-0.05 Degrees Celsius	Standard Deviation 0.163
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 12 hours	0.15 Degrees Celsius	Standard Deviation 0.266
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 2 hours	0.14 Degrees Celsius	Standard Deviation 0.19
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 3, 48 hours	0.01 Degrees Celsius	Standard Deviation 0.247
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 2, 24 hours	0.12 Degrees Celsius	Standard Deviation 0.148
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 2 hours	-0.03 Degrees Celsius	Standard Deviation 0.107
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 3, 48 hours	0.04 Degrees Celsius	Standard Deviation 0.156
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 12 hours	0.11 Degrees Celsius	Standard Deviation 0.162
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 2, 24 hours	0.06 Degrees Celsius	Standard Deviation 0.151
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 2 hours	-0.06 Degrees Celsius	Standard Deviation 0.141
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 3, 48 hours	0.01 Degrees Celsius	Standard Deviation 0.178
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 2, 24 hours	0.05 Degrees Celsius	Standard Deviation 0.175
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 12 hours	-0.04 Degrees Celsius	Standard Deviation 0.15
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 3, 48 hours	0.07 Degrees Celsius	Standard Deviation 0.222
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 2 hours	-0.04 Degrees Celsius	Standard Deviation 0.211
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 1, 12 hours	0.24 Degrees Celsius	Standard Deviation 0.188
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Body Temperature in MR Formulation	Day 2, 24 hours	0.08 Degrees Celsius	Standard Deviation 0.175

Secondary

Part A: Change From Baseline in Heart Rate in IR Formulation

Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. 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: 24 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in IR Formulation	Day 1, 2 hours	-2.6 Beats per minute	Standard Deviation 8.37
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in IR Formulation	Day 1, 12 hours	6.3 Beats per minute	Standard Deviation 11.51
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in IR Formulation	Day 2, 24 hours	-2.1 Beats per minute	Standard Deviation 7.73

Secondary

Part A: Change From Baseline in Heart Rate in MR Formulation

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 2 hours	-1.3 Beats per minute	Standard Deviation 7.22
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 12 hours	5.4 Beats per minute	Standard Deviation 9.62
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 2, 24 hours	0.7 Beats per minute	Standard Deviation 7.36
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 3, 48 hours	8.6 Beats per minute	Standard Deviation 11.39
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 2 hours	-6.1 Beats per minute	Standard Deviation 7.78
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 3, 48 hours	0.4 Beats per minute	Standard Deviation 8.58
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 12 hours	6.1 Beats per minute	Standard Deviation 9.79
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 2, 24 hours	-4.7 Beats per minute	Standard Deviation 8.72
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 3, 48 hours	3.8 Beats per minute	Standard Deviation 5.67
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 12 hours	9.8 Beats per minute	Standard Deviation 7.72
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 2, 24 hours	2.4 Beats per minute	Standard Deviation 8.56
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 2 hours	5.8 Beats per minute	Standard Deviation 6.87
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 2 hours	3.1 Beats per minute	Standard Deviation 7.33
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 12 hours	3.4 Beats per minute	Standard Deviation 10.19
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 3, 48 hours	4.7 Beats per minute	Standard Deviation 9.71
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 2, 24 hours	1.6 Beats per minute	Standard Deviation 9.21
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 3, 48 hours	7.3 Beats per minute	Standard Deviation 7.19
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 2, 24 hours	-2.4 Beats per minute	Standard Deviation 4.12
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 12 hours	8.8 Beats per minute	Standard Deviation 8.41
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Heart Rate in MR Formulation	Day 1, 2 hours	-1.3 Beats per minute	Standard Deviation 5.87

Secondary

Part A: Change From Baseline in Respiration Rate in IR Formulation

Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. 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: 24 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in IR Formulation	Day 1, 2 hours	-0.4 Breaths per minute	Standard Deviation 3.08
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in IR Formulation	Day 1, 12 hours	-0.2 Breaths per minute	Standard Deviation 2.1
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in IR Formulation	Day 2, 24 hours	-0.8 Breaths per minute	Standard Deviation 3.53

Secondary

Part A: Change From Baseline in Respiration Rate in MR Formulation

Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 2 hours; n=16, 16, 12, 16, 12	0.9 Breaths per minute	Standard Deviation 2.89
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 12 hours; n=15, 16, 12, 16, 12	1.1 Breaths per minute	Standard Deviation 1.68
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 2, 24 hours; n=16, 16, 12, 16, 12	1.4 Breaths per minute	Standard Deviation 1.93
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 3, 48 hours; n=16, 16, 12, 16, 12	2.3 Breaths per minute	Standard Deviation 3
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 2 hours; n=16, 16, 12, 16, 12	2.5 Breaths per minute	Standard Deviation 2.58
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 3, 48 hours; n=16, 16, 12, 16, 12	0.4 Breaths per minute	Standard Deviation 1.79
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 12 hours; n=15, 16, 12, 16, 12	0.8 Breaths per minute	Standard Deviation 1.94
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 2, 24 hours; n=16, 16, 12, 16, 12	0.9 Breaths per minute	Standard Deviation 2.58
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 3, 48 hours; n=16, 16, 12, 16, 12	4.0 Breaths per minute	Standard Deviation 2.37
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 12 hours; n=15, 16, 12, 16, 12	2.2 Breaths per minute	Standard Deviation 2.25
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 2, 24 hours; n=16, 16, 12, 16, 12	1.9 Breaths per minute	Standard Deviation 2.43
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 2 hours; n=16, 16, 12, 16, 12	2.8 Breaths per minute	Standard Deviation 2.29
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 2 hours; n=16, 16, 12, 16, 12	2.0 Breaths per minute	Standard Deviation 2.13
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 12 hours; n=15, 16, 12, 16, 12	0.9 Breaths per minute	Standard Deviation 2.14
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 3, 48 hours; n=16, 16, 12, 16, 12	0.7 Breaths per minute	Standard Deviation 1.99
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 2, 24 hours; n=16, 16, 12, 16, 12	2.2 Breaths per minute	Standard Deviation 1.64
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 3, 48 hours; n=16, 16, 12, 16, 12	-0.4 Breaths per minute	Standard Deviation 2.64
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 2, 24 hours; n=16, 16, 12, 16, 12	0.9 Breaths per minute	Standard Deviation 2.68
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 12 hours; n=15, 16, 12, 16, 12	2.1 Breaths per minute	Standard Deviation 3.34
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in Respiration Rate in MR Formulation	Day 1, 2 hours; n=16, 16, 12, 16, 12	0.0 Breaths per minute	Standard Deviation 3.25

Secondary

Part A: Change From Baseline in SBP and DBP in MR Formulation

SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. 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: 24 hours, Day 3: 48 hours

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 2 hours	-2.7 Millimeters of mercury	Standard Deviation 5.76
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 12 hours	-3.0 Millimeters of mercury	Standard Deviation 8.07
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day 2, 24 hours	-3.9 Millimeters of mercury	Standard Deviation 7.55
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day3, 48 hours,	-2.0 Millimeters of mercury	Standard Deviation 9.29
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 2 hours	-4.5 Millimeters of mercury	Standard Deviation 5.67
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 12 hours	-7.6 Millimeters of mercury	Standard Deviation 7.46
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day2, 24 hours	-2.4 Millimeters of mercury	Standard Deviation 6.3
Part A: IR 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day3, 48 hours	-3.7 Millimeters of mercury	Standard Deviation 6.26
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day 2, 24 hours	-10.3 Millimeters of mercury	Standard Deviation 8.69
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 12 hours	-8.3 Millimeters of mercury	Standard Deviation 5.35
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 2 hours	-7.9 Millimeters of mercury	Standard Deviation 6.82
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day3, 48 hours,	-5.3 Millimeters of mercury	Standard Deviation 7.15
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 12 hours	-6.9 Millimeters of mercury	Standard Deviation 8.32
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day3, 48 hours	-3.7 Millimeters of mercury	Standard Deviation 4.71
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 2 hours	-5.3 Millimeters of mercury	Standard Deviation 5.7
Part A: MR-18h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day2, 24 hours	-10.0 Millimeters of mercury	Standard Deviation 4.15
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day2, 24 hours	-6.6 Millimeters of mercury	Standard Deviation 5.76
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day3, 48 hours	-2.1 Millimeters of mercury	Standard Deviation 7.33
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day3, 48 hours,	-1.7 Millimeters of mercury	Standard Deviation 8.87
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 12 hours	-5.7 Millimeters of mercury	Standard Deviation 5.14
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day 2, 24 hours	-2.8 Millimeters of mercury	Standard Deviation 8.87
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 12 hours	-2.4 Millimeters of mercury	Standard Deviation 10.07
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 2 hours	-7.3 Millimeters of mercury	Standard Deviation 8.57
Part A: MR-16h 240 mg Fasted	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 2 hours	-6.1 Millimeters of mercury	Standard Deviation 3.53
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 12 hours	-0.09 Millimeters of mercury	Standard Deviation 13.02
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day 2, 24 hours	-6.8 Millimeters of mercury	Standard Deviation 5.72
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day3, 48 hours,	-4.2 Millimeters of mercury	Standard Deviation 7.74
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 2 hours	-6.9 Millimeters of mercury	Standard Deviation 5.11
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 12 hours	-5.9 Millimeters of mercury	Standard Deviation 6.35
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day3, 48 hours	-2.4 Millimeters of mercury	Standard Deviation 5.2
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 2 hours	-4.6 Millimeters of mercury	Standard Deviation 8.38
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day2, 24 hours	-4.5 Millimeters of mercury	Standard Deviation 4.93
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day3, 48 hours,	2.8 Millimeters of mercury	Standard Deviation 7.88
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day3, 48 hours	-1.1 Millimeters of mercury	Standard Deviation 7.74
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day 2, 24 hours	-2.3 Millimeters of mercury	Standard Deviation 7.01
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day2, 24 hours	-0.4 Millimeters of mercury	Standard Deviation 6.82
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 2 hours	-3.4 Millimeters of mercury	Standard Deviation 9.18
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 12 hours	-5.3 Millimeters of mercury	Standard Deviation 7.12
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	SBP, Day1, 12 hours	-1.3 Millimeters of mercury	Standard Deviation 10.54
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Change From Baseline in SBP and DBP in MR Formulation	DBP, Day1, 2 hours	-2.3 Millimeters of mercury	Standard Deviation 8.64

Secondary

Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation

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

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	SBP, Day 1, 2 hours	-3.9 Millimeters of mercury	Standard Deviation 6.29
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	SBP, Day 1, 12 hours	-3.3 Millimeters of mercury	Standard Deviation 6.39
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	SBP, Day 2, 24 hours	-6.6 Millimeters of mercury	Standard Deviation 7.26
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	DBP, Day1, 2 hours	-1.1 Millimeters of mercury	Standard Deviation 3
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	DBP, Day 1, 12 hours	-5.1 Millimeters of mercury	Standard Deviation 3.51
Part A: IR 240 mg Fasted	Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation	DBP, Day 2, 24 hours	-1.4 Millimeters of mercury	Standard Deviation 4.63

Secondary

Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation

Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 67

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation	Abnormal-Not Clinically Significant	8 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation	Abnormal - Clinically Significant	0 Participants

Secondary

Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation

Time frame: Up to Day 67

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal-Not Clinically Significant	8 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal - Clinically Significant	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal-Not Clinically Significant	10 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal - Clinically Significant	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal-Not Clinically Significant	5 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal - Clinically Significant	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal - Clinically Significant	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal-Not Clinically Significant	9 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal-Not Clinically Significant	7 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation	Abnormal - Clinically Significant	0 Participants

Secondary

Part A: Number of Participants With Abnormal Urinalysis Dipstick Results

Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed abnormal data for red blood cells (RBC): 1-9 High potential field (HPF) and WBC: 1-9/ HPF; WBC: 10-50/HPF has been presented.

Time frame: Day 2 (post-dose)

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	1 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	2 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	1 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	2 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	1 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	1 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	4 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	1 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	1 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	RBC 1-9/ HPF	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 10-50/HPF	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Abnormal Urinalysis Dipstick Results	WBC 1-9/HPF	3 Participants

Secondary

Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

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 that 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 67

Population: Safety Population consisted of all participants who receive at least 1 dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	2 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	5 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	3 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	3 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	3 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any AEs	4 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants

Secondary

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

Clinical chemistry parameters with PCI values:albumin (low: \<30 millimoles per liter\[mmol/L\]), Alanine transaminase (ALT) (high: \>=2xupper limit of normal \[ULN\]), Aspartate Aminotransferase(AST) (high: \>=2xULN), Alkaline phosphatase(ALP) (high:\>=2xULN), calcium(low: \<2 mmol/L, high: \>2.75 mmol/L),creatinine (high: \>44.2 mmol/L),glucose (low: \<3 mmol/L,high: \>9 mmol/L), potassium (low: \<3 mmol/L,high: \>5.5 mmol/L),sodium (low: \<130 mmol/L,high: \>150 mmol/L),total bilirubin(high :\>= 1.5xULN). 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 participants has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 67

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	12 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	14 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	2 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALT, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	AST, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	ALP, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Albumin, To Normal or no Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Calcium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Creatinine, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Glucose, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Potassium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Sodium, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria	Total Bilirubin, To Normal or No Change	12 Participants

Secondary

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

Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), total neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell (WBC) count (low: \<3\*10\^9/L and high: \>20\*10\^9/L). 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%. Data for worst-case post-Baseline has been reported.

Time frame: Up to Day 67

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	16 Participants
Part A: IR 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	16 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	12 Participants
Part A: MR-12h 240 mg Fed (High-Fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	16 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: MR-18h 240 mg Fed (High-fat)	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Normal or no Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Normal or No change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total neutrophils, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemotocrit, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hematocrit, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Total Neutrophils, To Normal or No Change	12 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Lymphocytes, To Low	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Platelet count, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	Hemoglobin, To High	0 Participants
Part A: MR-16h 240 mg Fasted	Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria	WBC count, To High	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026

A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation

Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation

Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation

Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation

Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast

Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation

Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation

Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation

Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)

Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation

Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg

Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation

Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation

Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation

Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation

Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast

Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State

Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State

Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State

Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State

Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State

Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State

Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State

Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast

Part A: Change From Baseline in Body Temperature in IR Formulation

Part A: Change From Baseline in Body Temperature in MR Formulation

Part A: Change From Baseline in Heart Rate in IR Formulation

Part A: Change From Baseline in Heart Rate in MR Formulation

Part A: Change From Baseline in Respiration Rate in IR Formulation

Part A: Change From Baseline in Respiration Rate in MR Formulation

Part A: Change From Baseline in SBP and DBP in MR Formulation

Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation

Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation

Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation

Part A: Number of Participants With Abnormal Urinalysis Dipstick Results

Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

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