Trial Outcomes & Findings for A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects (NCT NCT03305419)

Last Updated: 2023-10-10

Results Overview

An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

Up to Day 14

Results posted on

2023-10-10

Participant Flow

This study consisted of two parts; part A was single ascending dose, 3-way crossover and part B was repeat dose, sequential assignment which investigated the safety, tolerability, and pharmacokinetics of GSK2982772, in healthy participants.

A total of 62 participants (15 in Part A and 47 in Part B) were enrolled in the study. Participants were not enrolled into the GSK2982772 360 milligram (mg) twice daily (BID) arm of Part B as one participant in the 360 mg BID dose level in Part A exceeded the maximum concentration (Cmax) stopping criteria.

Participant milestones

Participant milestones
Measure	Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:GSK2982772 120 mg TID/240 mg TID/Placebo Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:Placebo/GSK2982772 240 mg TID/360 mg BID Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part B:Placebo Participants received matching oral placebo capsule to GSK2928772 for 14 days.	Part B:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days	Part B:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
Part A Period 1 (1Day) + Washout (7days) STARTED	3	3	3	3	0	0	0
Part A Period 1 (1Day) + Washout (7days) COMPLETED	3	2	3	3	0	0	0
Part A Period 1 (1Day) + Washout (7days) NOT COMPLETED	0	1	0	0	0	0	0
Part A Period 2 (1Day) + Washout (7days) STARTED	3	3	3	3	0	0	0
Part A Period 2 (1Day) + Washout (7days) COMPLETED	1	3	3	3	0	0	0
Part A Period 2 (1Day) + Washout (7days) NOT COMPLETED	2	0	0	0	0	0	0
Part A Period 3 (1Day) + Washout (7days) STARTED	3	3	3	3	0	0	0
Part A Period 3 (1Day) + Washout (7days) COMPLETED	3	3	3	3	0	0	0
Part A Period 3 (1Day) + Washout (7days) NOT COMPLETED	0	0	0	0	0	0	0
Part B (14 Days) STARTED	0	0	0	0	14	20	13
Part B (14 Days) COMPLETED	0	0	0	0	11	10	8
Part B (14 Days) NOT COMPLETED	0	0	0	0	3	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:GSK2982772 120 mg TID/240 mg TID/Placebo Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part B:Placebo Participants received matching oral placebo capsule to GSK2928772 for 14 days.	Part B:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days	Part B:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.
Part A Period 1 (1Day) + Washout (7days) Adverse Event	0	1	0	0	0
Part A Period 2 (1Day) + Washout (7days) Adverse Event	1	0	0	0	0
Part A Period 2 (1Day) + Washout (7days) Physician Decision	1	0	0	0	0
Part B (14 Days) Adverse Event	0	0	1	2	4
Part B (14 Days) Physician Decision	0	0	2	8	1

Baseline Characteristics

A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID n=5 Participants Participants received oral capsule of 120 mg GSK2982772 three times a day in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:GSK2982772 120 mg TID/240 mg TID/Placebo n=4 Participants Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID n=3 Participants Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part A:Placebo/GSK2982772 240 mg TID/360 mg BID n=3 Participants Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days.	Part B:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772 for 14 days.	Part B:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days	Part B:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days.	Part B:GSK2982772 360 mg TID Participants received GSK2982772 oral capsule at a dose of 360 mg TID for 14 days.	Total n=62 Participants Total of all reporting groups
Age, Continuous	36.2 Years STANDARD_DEVIATION 9.04 • n=5 Participants	42.5 Years STANDARD_DEVIATION 9.95 • n=7 Participants	59.0 Years STANDARD_DEVIATION 3.61 • n=5 Participants	49.0 Years STANDARD_DEVIATION 10.00 • n=4 Participants	39.1 Years STANDARD_DEVIATION 9.66 • n=21 Participants	43.3 Years STANDARD_DEVIATION 10.87 • n=8 Participants	38.6 Years STANDARD_DEVIATION 11.03 • n=8 Participants	—	45.25 Years STANDARD_DEVIATION 9.16 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants	20 Participants n=8 Participants	13 Participants n=8 Participants	0 Participants n=24 Participants	57 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	—	6 Participants n=42 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	—	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	—	1 Participants n=42 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Herit	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants	19 Participants n=8 Participants	10 Participants n=8 Participants	—	54 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to Day 14

Population: Safety population. Safety population consists of all randomized participants who take at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Subjects With Adverse Events (AEs) and Serious AEs (SAEs): Part A SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Adverse Events (AEs) and Serious AEs (SAEs): Part A AEs	3 Participants	6 Participants	4 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: Safety population. GSK2982772 360 mg BID was not started in Part B as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With AEs and SAEs: Part B AEs	9 Participants	17 Participants	12 Participants	—
Number of Participants With AEs and SAEs: Part B SAEs	1 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to Week 9

Population: Safety population

Blood samples were collected from participants for the analysis of following clinical chemistry parameters: alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were \>=2 times Upper Limit of Normal (ULN) units per liter (U/L) for ALT, \<30 grams per liter (g/L) for albumin, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \<2 or \>2.75 millimoles per liter (mmol/L) for calcium, \>44.2 micromoles per liter (µmol/L) for creatinine, \<3 or \>9 mmol/L for glucose, \<3 or \>5.5 mmol/L for potassium, \<130 or \>150 mmol/L for sodium and \>=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A ALT, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A ALT, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A ALT, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Albumin, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Albumin, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Albumin, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Alkaline phosphatase, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Alkaline phosphatase, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Alkaline phosphatase, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A AST, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A AST, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A AST, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Calcium, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Calcium, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Calcium, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Creatinine, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Creatinine, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Creatinine, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Glucose, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Glucose, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Glucose, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Potassium, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Potassium, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Potassium, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Sodium, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Sodium, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Sodium, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Total Bilirubin, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Total Bilirubin, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A Total Bilirubin, High	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria

Blood samples were collected from participants for the analysis of following clinical chemistry parameters: ALT, albumin, alkaline phosphatase, AST, calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were \>=2 times ULN U/L for ALT, \<30 g/L for albumin, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \<2 or \>2.75 mmol/L for calcium, \>44.2 µmol/L for creatinine, \<3 or \>9 mmol/L for glucose, \<3 or \>5.5 mmol/L for potassium, \<130 or \>150 mmol/L for sodium and \>=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Albumin, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B ALT, No change	14 Participants	19 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Calcium, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Calcium, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Creatinine, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Creatinine, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Creatinine, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Glucose, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Glucose, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Potassium, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Potassium, No change	14 Participants	20 Participants	12 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Potassium, High	0 Participants	0 Participants	1 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Sodium, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Sodium, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Sodium, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Total Bilirubin, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Total Bilirubin, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Total Bilirubin, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Albumin, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B ALT, High	0 Participants	1 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Albumin, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Alkaline phosphatase, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Alkaline phosphatase, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Alkaline phosphatase, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B AST, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B AST, No change	14 Participants	19 Participants	13 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B AST, High	0 Participants	1 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Calcium, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B ALT, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B Glucose, No change	14 Participants	20 Participants	13 Participants	—

PRIMARY outcome

Timeframe: Up to Week 9

Population: Safety population.

Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and white blood cell (WBC) counts. PCI ranges were \>0.54 or \< 0.075 proportion of red blood cells (RBC) in blood for hematocrit, \<25 or \>180 g/L for hemoglobin, 0.8 x10\^9 cells/L for lymphocytes, \<1.5 x10\^9 cells/L for neutrophils, \<100 or \>550 x10\^9 cells/L for platelets and \<3 or 20\> x 10\^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hematocrit, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hematocrit, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hematocrit, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hemoglobin, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hemoglobin, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Hemoglobin, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Lymphocytes, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Lymphocytes, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Platelet, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Lymphocytes, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Platelet count, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Platelet, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Total Neutrophils, Low	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Total Neutrophils, No change	8 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A Total Neutrophils, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A WBC count, Low	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A WBC, No change	9 Participants	9 Participants	9 Participants	9 Participants
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A WBC, High	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria

Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and WBC counts. PCI ranges were \>0.54 or \< 0.075 proportion of RBC in blood for hematocrit, \<25 or \>180 g/L for hemoglobin, 0.8 x10\^9 cells/L for lymphocytes, \<1.5 x10\^9 cells/L for neutrophils, \<100 or \>550 x10\^9 cells/L for platelets and \<3 or 20\> x 10\^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hematocrit, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hematocrit, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hematocrit, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hemoglobin, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hemoglobin, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Hemoglobin, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Lymphocytes, Low	0 Participants	0 Participants	1 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Lymphocytes, No change	14 Participants	20 Participants	12 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Lymphocytes, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Platelet, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Total Neutrophils, No change	14 Participants	19 Participants	10 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Total Neutrophils, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B WBC count, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B WBC, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B WBC, High	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Platelet count, Low	0 Participants	0 Participants	0 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Platelet, No change	14 Participants	20 Participants	13 Participants	—
Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B Total Neutrophils, Low	0 Participants	1 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Up to Week 9

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

Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=3 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=1 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=1 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=1 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Urinalysis Results: Part A Cellular casts, No change	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Cellular casts, Any increase	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Cellular casts, Increase to 1-9/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Granular casts, No change	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Granular casts, Any increase	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Granular casts, Increase 1-9/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Granular casts, Increase 10-50/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Hyaline casts, No change	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Hyaline casts, Any increase	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Hyaline casts, Increase 1-9/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Hyaline casts, Increase 10-50/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A RBC, No change	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A RBC, Any increase	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A RBC, Increase 1-9/HPF	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A RBC, Increase 10-50/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A WBC, Increase 10-50/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A Cellular casts, Increase to 10-50/HPF	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A WBC, No change	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Urinalysis Results: Part A WBC, Any increase	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Case Urinalysis Results: Part A WBC, Increase 1-9/HPF	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria. Only those participants with data available at specified timepoints were analyzed.

Outcome measures

Outcome measures
Measure	Part A:Placebo Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=7 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=2 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Worst Case Urinalysis Results: Part B Cellular casts, No change	—	7 Participants	2 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Cellular casts, Increase to 1-9/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Cellular casts, Increase to 10-50/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Granular casts, No change	—	7 Participants	2 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Granular casts, Any increase	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Granular casts, Increase 1-9/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Granular casts, Increase 10-50/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Hyaline casts, No change	—	7 Participants	2 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Hyaline casts, Any increase	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Hyaline casts, Increase 1-9/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Hyaline casts, Increase 10-50/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B RBC, No change	—	5 Participants	1 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B RBC, Increase 1-9/HPF	—	2 Participants	1 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B RBC, Increase 10-50/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B WBC, No change	—	5 Participants	2 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B WBC, Any increase	—	2 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B WBC, Increase 1-9/HPF	—	2 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B WBC, Increase 10-50/HPF	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B Cellular casts, Any increase	—	0 Participants	0 Participants	—
Number of Participants With Worst Case Urinalysis Results: Part B RBC, Any increase	—	2 Participants	1 Participants	—

PRIMARY outcome

Timeframe: Up to Week 9

Population: Safety population

Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure \<85 and \>160 millimeters of mercury \[mmHg\]), diastolic blood pressure \<45 mmHg and \>100 mmHg, heart rate \<40 and \>100 beats per minute, body temperature \<=35.5 and \>=37.8 degrees Celsius and respiration rate \<=8 and \>=20 breaths per minute. Data of participants with potential clinical importance has been reported.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Abnormal Vital Signs: Part A	6 Participants	8 Participants	7 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria

Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure \<85 and \>160 mmHg, diastolic blood pressure \<45 mmHg and \>100 mmHg, heart rate \<40 and \>100 beats per minute, body temperature \<=35.5 and \>=37.8 degrees Celsius and respiration rate \<=8 and \>=20 breaths per minute. Data of participants with potential clinical importance has been reported.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Abnormal Vital Signs: Part B	11 Participants	20 Participants	12 Participants	—

PRIMARY outcome

Timeframe: Up to Day 4

Population: Safety population

12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. 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.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Abnormal Electrocardiogram (ECG) Findings: Part A Abnormal, clinically significant	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings: Part A Abnormal, not clinically significant	1 Participants	0 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Number of Participants With Abnormal ECG Findings: Part B Abnormal, not clinically significant	3 Participants	4 Participants	3 Participants	—
Number of Participants With Abnormal ECG Findings: Part B Abnormal, clinically significant	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day1

Population: Pharmacokinetic population. Pharmacokinetic population consists of participants in the safety population for whom a pharmacokinetic sample were obtained and analyzed.

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours (AUC[0-24]) Following TID Dosing of GSK2982772: Part A	21.22 Hours*microgram per millilter Geometric Coefficient of Variation 41.37	46.13 Hours*microgram per millilter Geometric Coefficient of Variation 37.38	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20min, 40min, 1hr, 1hr 30min, 2hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr, 12hr 20min, 12hr 40min, 13hr, 13hr 30min, 14hr, 15hr, 16hr, 19hr, 22hr, 24hr post dose on Day 1.

Population: Pharmacokinetic population.

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC(0-24) Following BID Dosing of GSK2982772: Part A	54.02 Hours*microgram per millilter Geometric Coefficient of Variation 36.02	—	—	—

SECONDARY outcome

Population: Pharmacokinetic population. Only those participants with data available at the specified timepoints were analyzed.

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC[0-24] Following TID Dosing of GSK2982772: Part B	25.67 Hours*microgram per millilter Geometric Coefficient of Variation 28.81	52.00 Hours*microgram per millilter Geometric Coefficient of Variation 45.26	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (0-7) Following TID Dosing of GSK2982772 : Part A	6.053 Hours*microgram per millilter Geometric Coefficient of Variation 33.87	11.686 Hours*microgram per millilter Geometric Coefficient of Variation 33.50	—	—

SECONDARY outcome

Timeframe: 7 hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (7-14) Following TID Dosing of GSK2982772 : Part A	7.829 Hours*microgram per millilter Geometric Coefficient of Variation 44.25	17.823 Hours*microgram per millilter Geometric Coefficient of Variation 42.11	—	—

SECONDARY outcome

Timeframe: 14 hours, 14 hours 20 and 40 minutes, 15 hours ,15 hours 30 minutes, 16, 19, 22 and 24 hours on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (14-24) Following TID Dosing of GSK2982772 : Part A	7.213 Hours*microgram per millilter Geometric Coefficient of Variation 48.85	16.300 Hours*microgram per millilter Geometric Coefficient of Variation 39.72	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours,12 hours on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (0-12) Following BID Dosing of GSK2982772 in Part A	21.80 Hours*microgram per millilter Geometric Coefficient of Variation 24.41	—	—	—

SECONDARY outcome

Timeframe: 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (12-24) Following BID Dosing of GSK2982772 in Part A	31.69 Hours*microgram per millilter Geometric Coefficient of Variation 48.02	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 1 and 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=20 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC(0-7) Following TID Dosing of GSK2982772 in Part B AUC (0-7), Day 1, n=20, 13	6.550 Hour*microgram per millilter Geometric Coefficient of Variation 37.67	11.895 Hour*microgram per millilter Geometric Coefficient of Variation 33.98	—	—
AUC(0-7) Following TID Dosing of GSK2982772 in Part B AUC (0-7), Day 14, n=10, 9	7.485 Hour*microgram per millilter Geometric Coefficient of Variation 25.53	14.835 Hour*microgram per millilter Geometric Coefficient of Variation 45.30	—	—

SECONDARY outcome

Timeframe: 7 and 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (7-14) Following TID Dosing of GSK2982772 in Part B	9.095 Hours*microgram per millilter Geometric Coefficient of Variation 30.57	17.372 Hours*microgram per millilter Geometric Coefficient of Variation 34.96	—	—

SECONDARY outcome

Timeframe: 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC (14-24) Following TID Dosing of GSK2982772 in Part B	8.988 Hours*microgram per millilter Geometric Coefficient of Variation 33.57	19.816 Hours*microgram per millilter Geometric Coefficient of Variation 55.60	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Maximum Observed Plasma Drug Concentration Cmax (0-7) Following TID Dosing of GSK2982772 in Part A	1.7672 Microgram per milliliter Geometric Coefficient of Variation 41.78	3.3125 Microgram per milliliter Geometric Coefficient of Variation 25.88	—	—

SECONDARY outcome

Timeframe: 7 hours, 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (7-14) Following TID Dosing of GSK2982772 in Part A	2.148 Microgram per milliliter Geometric Coefficient of Variation 36.24	5.007 Microgram per milliliter Geometric Coefficient of Variation 33.09	—	—

SECONDARY outcome

Timeframe: 14 hours, 14 hours 20 and 40 minutes, 15 and 15 hours 30 minutes, 16, 19, 22 and 24 hours post dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (14-24) Following TID Dosing of GSK2982772 in Part A	1.4156 Microgram per milliliter Geometric Coefficient of Variation 47.03	3.4812 Microgram per milliliter Geometric Coefficient of Variation 28.46	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (0-12) Following BID Dosing of GSK2982772 in Part A	4.967 Microgram per milliliter Geometric Coefficient of Variation 30.75	—	—	—

SECONDARY outcome

Timeframe: 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (12-24) Following BID Dosing of GSK2982772 in Part A	6.965 Microgram per milliliter Geometric Coefficient of Variation 61.70	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=20 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (0-7) Following TID Dosing of GSK2982772 in Part B Cmax (0-7), Day 14, n=10, 9	2.2239 Microgram per milliliter Geometric Coefficient of Variation 30.03	4.3784 Microgram per milliliter Geometric Coefficient of Variation 45.62	—	—
Cmax (0-7) Following TID Dosing of GSK2982772 in Part B Cmax (0-7), Day 1, n=20, 13	2.0883 Microgram per milliliter Geometric Coefficient of Variation 37.87	3.2333 Microgram per milliliter Geometric Coefficient of Variation 37.04	—	—

SECONDARY outcome

Timeframe: 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (7-14) Following TID Dosing of GSK2982772 in Part B	2.505 Microgram per milliliter Geometric Coefficient of Variation 26.70	5.435 Microgram per milliliter Geometric Coefficient of Variation 32.59	—	—

SECONDARY outcome

Timeframe: 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (14-24) Following TID Dosing of GSK2982772 in Part B	1.9205 Microgram per millilter Geometric Coefficient of Variation 30.82	4.1607 Microgram per millilter Geometric Coefficient of Variation 38.79	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Time to Cmax (Tmax) (0-7) Following TID Dosing of GSK2982772 in Part A	3.008 Hours Interval 2.0 to 5.02	2.043 Hours Interval 1.5 to 3.01	—	—

SECONDARY outcome

Timeframe: 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (7-14) Following TID Dosing of GSK2982772 in Part A	10.000 Hours Interval 8.0 to 12.0	9.000 Hours Interval 8.5 to 10.02	—	—

SECONDARY outcome

Timeframe: 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 1

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (14-24) Following TID Dosing of GSK2982772 in Part A	19.00 Hours Interval 16.0 to 22.0	17.02 Hours Interval 16.0 to 24.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1hour, 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (0-12) Following BID Dosing of GSK2982772 in Part A	3.000 Hours Interval 1.5 to 4.02	—	—	—

SECONDARY outcome

Timeframe: 12 hours, 12 hours 20 and 40 minutes, 13 hours, 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1

Population: Pharmacokinetic population.

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (12-24) Following BID Dosing of GSK2982772 in Part A	14.01 Hours Interval 13.5 to 15.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=20 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (0-7) Following TID Dosing of GSK2982772 Part B Tmax (0-7), Day 1, n=20, 13	2.000 Hours Interval 1.0 to 3.01	3.000 Hours Interval 1.0 to 3.01	—	—
Tmax (0-7) Following TID Dosing of GSK2982772 Part B Tmax (0-7), Day 14, n=10, 9	1.750 Hours Interval 1.0 to 3.03	2.003 Hours Interval 1.0 to 3.0	—	—

SECONDARY outcome

Timeframe: 7hours and 7 hours 20 and 40 minutes, 8hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (7-14) Following TID Dosing of GSK2982772 in Part B	9.001 Hours Interval 8.5 to 10.0	10.008 Hours Interval 8.5 to 12.0	—	—

SECONDARY outcome

Timeframe: 14hours, 14 hours 20 and 40 minutes, 15 hours and 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (14-24) Following TID Dosing of GSK2982772 in Part B	17.02 Hours Interval 15.0 to 19.0	18.92 Hours Interval 16.0 to 19.0	—	—

SECONDARY outcome

Timeframe: 7 hours post-dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Observed Trough Plasma Drug Concentration at 7 Hour (C7),Following TID Dosing of GSK2982772 in Part A	0.3614 Microgram per milliliter Geometric Coefficient of Variation 84.67	0.7723 Microgram per milliliter Geometric Coefficient of Variation 89.30	—	—

SECONDARY outcome

Timeframe: 14 hours post-dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Observed Trough Plasma Drug Concentration at 14 Hours (C14) Following TID Dosing of GSK2982772 in Part A	0.4318 Microgram per milliliter Geometric Coefficient of Variation 86.28	0.7487 Microgram per milliliter Geometric Coefficient of Variation 76.95	—	—

SECONDARY outcome

Timeframe: 24 hours post-dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C24 Following TID Dosing of GSK2982772 in Part A	0.34518 Microgram per milliliter Geometric Coefficient of Variation 82.34	0.59880 Microgram per milliliter Geometric Coefficient of Variation 158.88	—	—

SECONDARY outcome

Timeframe: 12 hours post-dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C12 Following BID Dosing of GSK2982772 in Part A	0.3490 Microgram per millilter Geometric Coefficient of Variation 98.83	—	—	—

SECONDARY outcome

Timeframe: 24 hours post-dose on Day 1

Population: Pharmacokinetic population

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=9 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C24 Following BID Dosing of GSK2982772 in Part A	0.36965 Microgram per millililter Geometric Coefficient of Variation 101.70	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=8 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C0 Following TID Dosing of GSK2982772 in Part B	0.29926 Microgram per milliliter Geometric Coefficient of Variation 56.63	0.57528 Microgram per milliliter Geometric Coefficient of Variation 136.34	—	—

SECONDARY outcome

Timeframe: 7 hours post-dose on Days 1 and 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=20 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C7 Following TID Dosing of GSK2982772 in Part B C7, Day 1, n=20, 13	0.3345 Microgram per milliliter Geometric Coefficient of Variation 50.78	0.6105 Microgram per milliliter Geometric Coefficient of Variation 57.01	—	—
C7 Following TID Dosing of GSK2982772 in Part B C7, Day 14, n=10, 9	0.3718 Microgram per milliliter Geometric Coefficient of Variation 43.85	0.6885 Microgram per milliliter Geometric Coefficient of Variation 75.98	—	—

SECONDARY outcome

Timeframe: 14 hours post-dose on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C14 Following TID Dosing of GSK2982772 in Part B	0.3830 Microgram per milliliter Geometric Coefficient of Variation 53.04	0.6912 Microgram per milliliter Geometric Coefficient of Variation 106.01	—	—

SECONDARY outcome

Timeframe: 24 hours post-dose on Day 14

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=10 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
C24 Following TID Dosing of GSK2982772 in Part B	0.22712 Microgram per milliliter Geometric Coefficient of Variation 60.78	0.33342 Microgram per milliliter Geometric Coefficient of Variation 180.82	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
AUC([0-7] Following TID Dosing of GSK2982772 in Fed State of Part B AUC (0-7) following high fat breakfast, Day 11	6.874 Hours*micrograms per milliliter Geometric Coefficient of Variation 24.64	15.987 Hours*micrograms per milliliter Geometric Coefficient of Variation 42.86	—	—
AUC([0-7] Following TID Dosing of GSK2982772 in Fed State of Part B AUC (0-7) following normal breakfast, Day 9	7.743 Hours*micrograms per milliliter Geometric Coefficient of Variation 31.46	14.691 Hours*micrograms per milliliter Geometric Coefficient of Variation 37.63	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Cmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B Cmax(0-7), following Normal Breakfast, Day 9	2.0918 Microgram per milliliter Geometric Coefficient of Variation 21.74	3.9440 Microgram per milliliter Geometric Coefficient of Variation 33.82	—	—
Cmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B Cmax(0-7), following High Fat Breakfast, Day 11	1.8098 Microgram per milliliter Geometric Coefficient of Variation 29.77	4.1171 Microgram per milliliter Geometric Coefficient of Variation 58.36	—	—

SECONDARY outcome

Timeframe: Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11

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

Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Part A:Placebo n=14 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Tmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B Tmax(0-7), Day 9	3.000 Hours Interval 1.04 to 5.0	3.000 Hours Interval 2.0 to 5.03	—	—
Tmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B Tmax (0-7), Day 11	4.000 Hours Interval 1.5 to 5.0	3.000 Hours Interval 2.0 to 5.0	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 and 24 hours post first dose on Day 14

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

Blood samples were collected into EDTA tubes and processed to plasma for 4 beta-hydroxycholesterol and cholesterol. Ratio of 4 beta-hydroxycholesterol to cholesterol is presented

Outcome measures

Outcome measures
Measure	Part A:Placebo n=1 Participants Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=20 Participants Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A:GSK2982772 240 mg TID n=13 Participants Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A:GSK2982772 360 mg BID Participants received GSK2982772 oral capsule at a dose of 360 mg BID
Ratio of Plasma 4 Beta-hydroxycholesterol to Cholesterol: Part B Day 1, Pre-dose; n=0, 19, 12	—	0.000019 Ratio Standard Deviation 0.0000064	0.000023 Ratio Standard Deviation 0.0000099	—
Ratio of Plasma 4 Beta-hydroxycholesterol to Cholesterol: Part B Day 14, 24 hour; n=1, 10, 9	0.000016 Ratio Standard Deviation NA Not applicable (NA) indicates that standard deviation could not be calculated for a single participant.	0.000021 Ratio Standard Deviation 0.0000089	0.000024 Ratio Standard Deviation 0.0000065	—

Adverse Events

Part A: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A:GSK2982772 120 mg TID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: GSK2982772 240 mg TID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: GSK2982772 360 mg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B:Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part B: GSK2982772 120 mg TID

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Part B: GSK2982772 240 mg TID

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part B: GSK2982772 360 mg BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=9 participants at risk Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A: GSK2982772 240 mg TID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A: GSK2982772 360 mg BID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 360 mg BID	Part B:Placebo n=14 participants at risk Participants received matching oral placebo capsule to GSK2928772 for 14 days.	Part B: GSK2982772 120 mg TID n=20 participants at risk Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days	Part B: GSK2982772 240 mg TID n=13 participants at risk Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days	Part B: GSK2982772 360 mg BID Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg TID for 14 days
Nervous system disorders Cerebrovascular accident	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure	Part A: Placebo n=9 participants at risk Participants received matching oral placebo capsule to GSK2928772	Part A:GSK2982772 120 mg TID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 120 mg TID	Part A: GSK2982772 240 mg TID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 240 mg TID	Part A: GSK2982772 360 mg BID n=9 participants at risk Participants received GSK2982772 oral capsule at a dose of 360 mg BID	Part B:Placebo n=14 participants at risk Participants received matching oral placebo capsule to GSK2928772 for 14 days.	Part B: GSK2982772 120 mg TID n=20 participants at risk Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days	Part B: GSK2982772 240 mg TID n=13 participants at risk Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days	Part B: GSK2982772 360 mg BID Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg TID for 14 days
Skin and subcutaneous tissue disorders Dermatitis contact	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	22.2% 2/9 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	33.3% 3/9 • Number of events 3 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	33.3% 3/9 • Number of events 3 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	21.4% 3/14 • Number of events 4 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	20.0% 4/20 • Number of events 4 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Faeces soft	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	10.0% 2/20 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Flatulence	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	22.2% 2/9 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	22.2% 2/9 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Medical device site dermatitis	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Influenza like illness	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Thirst	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Infections and infestations Escherichia urinary tract infection	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	14.3% 2/14 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Psychiatric disorders Abnormal dreams	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	22.2% 2/9 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	20.0% 4/20 • Number of events 4 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Investigations Blood creatinine increased	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Vascular disorders Hypertension	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	11.1% 1/9 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Nervous system disorders Headache	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	14.3% 2/14 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	15.0% 3/20 • Number of events 3 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	15.4% 2/13 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	15.4% 2/13 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Nervous system disorders Lethargy	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	10.0% 2/20 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Catheter site bruise	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	15.0% 3/20 • Number of events 3 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Fatigue	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	15.0% 3/20 • Number of events 3 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	10.0% 2/20 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	10.0% 2/20 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Cardiac disorders Atrial tachycardia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	14.3% 2/14 • Number of events 2 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Catheter site pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Catheter site swelling	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Feeling hot	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
General disorders Vessel puncture site pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Nervous system disorders Tremor	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Cardiac disorders Tachycardia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Infections and infestations Hordeolum	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Infections and infestations Oral herpes	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Psychiatric disorders Anxiety	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Psychiatric disorders Mood altered	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Psychiatric disorders Nightmare	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Renal and urinary disorders Polyuria	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Immune system disorders Seasonal allergy	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Eye disorders Ocular hyperaemia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Ear and labyrinth disorders Ear disorder	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Vascular disorders Hot flush	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Vascular disorders Thrombophlebitis superficial	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	5.0% 1/20 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Investigations Antinuclear antibody positive	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/13 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.
Investigations Haemoglobin decreased	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/9 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/14 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	0.00% 0/20 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	7.7% 1/13 • Number of events 1 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.	— 0/0 • On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B. Safety population consists of all randomized participants who take at least 1 dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER