A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03372603
• Collaborator: Biomedical Advanced Research and Development Authority (U.S. Fed)
• Enrollment: 17
• Locations: 8
• Arms: 2
• Actual Duration (Months): 6.1
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and will be randomized to one of the following treatments in each period: A) Placebo matching to GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total duration of participation in the study will be maximum of 10 and a half weeks including follow-up visit.

Condition or Disease	Intervention/Treatment	Phase
Cough	Drug: GSK2798745; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study. Each subject will be screened (screening may be conducted across more than 1 visit); each subject will have 2 treatment periods (each 7 days) with a washout period of 14 to 21 days between the treatment periods; and each subject will have a follow-up visit (within 7 to 10 days after their last dose). Each subject will be involved in the study for a maximum of 10 and a half weeks.This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study. Each subject will be screened (screening may be conducted across more than 1 visit); each subject will have 2 treatment periods (each 7 days) with a washout period of 14 to 21 days between the treatment periods; and each subject will have a follow-up visit (within 7 to 10 days after their last dose). Each subject will be involved in the study for a maximum of 10 and a half weeks.
• Masking: Double (Participant, Investigator)
• Masking Description: All study staff involved in clinical assessments (which includes the investigator, sub-investigators, other site staff), and the subject will be blinded to the treatment allocated to individual subjects.
• Primary Purpose: Treatment
• Official Title: A Placebo-controlled, Double-blind (Sponsor Open), Randomized, Crossover Study to Assess the Efficacy, Safety, and Tolerability of GSK2798745 in Participants With Chronic Cough
• Actual Study Start Date: Apr 5, 2018
• Actual Primary Completion Date: Oct 8, 2018
• Actual Study Completion Date: Oct 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence AB Subjects will receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days).	Drug: GSK2798745; GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient [API]) to be taken with a glass of water (approximately 240 mL).; Drug: Placebo; Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).
Experimental: Treatment Sequence BA Subjects will receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days).	Drug: GSK2798745; GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient [API]) to be taken with a glass of water (approximately 240 mL).; Drug: Placebo; Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).

Outcome Measures

Primary Outcome Measures

1. Total Cough Counts During Day Time Hours Following 7-days of Dosing [Up to 10 hours post-dose on Day 7 of each treatment period]

   Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.

Secondary Outcome Measures

1. Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to 45 days]

   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.

2. Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK) [Baseline (Day -1) and Day 8 of each treatment period]

   Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

3. Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine [Baseline (Day -1) and Day 8 for each treatment period]

   Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

4. Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea [Baseline (Day -1) and Day 8 of each treatment period]

   Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

5. Change From Baseline Values for Clinical Chemistry Parameter: Total Protein [Baseline (Day -1) and Day 8 of each treatment period]

   Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

6. Number of Participants With Abnormal Values of Cardiac Troponin [Up to 45 days]

   Cardiac troponin values was measured in participants.

7. Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count [Baseline (Day -1) and Day 8 of each treatment period]

   Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

8. Change From Baseline Values for Hematology Parameter: Hemoglobin [Baseline (Day -1) and Day 8 for each treatment period]

   Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

9. Change From Baseline Values for Hematology Parameter: Hematocrit [Baseline (Day -1) and Day 8 of each treatment period]

   Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

10. Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) [Baseline (Day -1) and Day 8 for each treatment period]

    Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

11. Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV) [Baseline (Day -1) and Day 8 of each treatment period]

    Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

12. Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count [Baseline (Day -1) and Day 8 for each treatment period]

    Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

13. Change From Baseline Values for Hematology Parameter: Reticulocytes [Baseline (Day -1) and Day 8 for each treatment period]

    Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

14. Number of Participants With Abnormal Urinalysis Data [Up to Day 8]

    Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.

15. Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) [Baseline (pre-dose on Day 1) and Day 8 of each treatment period]

    Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

16. Change From Baseline in Temperature [Baseline (pre-dose on Day 1) and Day 8 of each treatment period]

    Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

17. Change From Baseline in Heart Rate [Baseline (pre-dose on Day 1) and Day 8 of each treatment period]

    Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.

18. Number of Participants With Abnormal Electrocardiogram (ECG) Findings [Baseline (pre-dose on Day 1) and Day 8 of each treatment period]

    Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 18 and 75 years of age inclusive, at the time of signing the informed consent.

• Chronic idiopathic cough for >=1 year (before screening), defined as: a cough that is unresponsive to at least 8 weeks of targeted treatment, or a cough for which no objective evidence of an underlying trigger has been determined, despite medical investigations.

• No significant findings on chest imaging (chest X-ray [CXR] or Computed tomography scan) within 12 months before screening (subjects with an abnormal CXR within 12 months, from a temporary process, will be allowed to participate if a repeat CXR is normal).

• Forced expiratory volume in one second (FEV1) >=80% of the predicted normal value (at screening), or documented evidence of FEV1 >=80% within the 6 months before screening.

• Score of >=40 millimeters (mm) on the Cough Severity Visual Analogue Scale (VAS) at Screening.

• Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18 to 40 kilogram per meter square (kg/m^2) (inclusive) at screening.

• A male participant must agree to follow the contraception requirements stated in the protocol from the time of first dose of study treatment until 2 weeks after last dose of study treatment, and refrain from donating sperm during this period.

• A female participant is eligible to participate if she is not of childbearing potential.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

• History or current evidence of any serious or clinically significant gastrointestinal, renal, endocrine, neurologic, hematologic or other condition that is uncontrolled on permitted therapies or that would, in the opinion of the investigator or the medical monitor, make the subject unsuitable for inclusion in this study.

• History or current evidence of chronic productive cough.

• History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the 6 months before screening.

• Active ulcer disease or gastrointestinal bleeding at the time of screening (positive fecal occult blood test [FOBT] at screening).

• History of stroke or seizure disorder within 5 years of screening.

• Respiratory tract infection within 6 weeks of screening.

• Subject who, in the investigator's opinion, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any evidence of suicidal ideation on any questionnaires e.g. Type 4 or 5 on the Columbia Suicidality Severity Rating Scale (C-SSRS) in the last 6 months (assessed at screening).

• Alanine transferase (ALT) > twice the upper limit of normal (ULN) at screening.

• Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening.

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec in subjects with bundle branch block at screening.

• Use of a listed prohibited medication within the restricted timeframe relative to the first dose of study treatment.

• Use of a strong inhibitors or inducers of cytochrome P450 (CYP) 3A or pglycoprotein.

• Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months of screening.

• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.

• Current enrollment or past participation within the 3 months before screening in any clinical study involving an investigational study treatment or any other type of medical research.

• Positive human immunodeficiency virus (HIV) antibody test at screening.

• Presence of Hepatitis B surface antigen (HBsAg) at screening.

• Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.

• Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.

• Cardiac troponin at screening > ULN for the assay.

• History of alcohol abuse within 6 months of screening, in the opinion of the investigator.

• Current smoker or history of smoking within the 6 months before screening, or a cumulative history of >= 20 pack years. Pack years = (Number of cigarettes smoked/day/20) x (Number of years smoked)

• Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Manchester	Lancashire	United Kingdom	M23 9LT
2	GSK Investigational Site	Manchester	Lancashire	United Kingdom	M23 9L
3	GSK Investigational Site	Belfast		United Kingdom	BT9 7BL
4	GSK Investigational Site	Belfast		United Kingdom	BT9 7B
5	GSK Investigational Site	Cottingham		United Kingdom	HU16 5JQ
6	GSK Investigational Site	Cottingham		United Kingdom	HU16 5
7	GSK Investigational Site	North Shields		United Kingdom	NE29 8NH
8	GSK Investigational Site	North Shields		United Kingdom	NE29 8

Sponsors and Collaborators

• GlaxoSmithKline
• Biomedical Advanced Research and Development Authority

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline
• Study Director: GSK Clinical Trials, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Documents (Full-Text)

• Study Protocol - Jun 25, 2018
• Statistical Analysis Plan - Sep 7, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03372603
• Other Study ID Numbers: 207702; 2017-002265-21
• First Posted: Dec 13, 2017
• Last Update Posted: Oct 2, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: GSK2798745, efficacy, safety, chronic cough, crossover study
• Additional relevant MeSH terms: Cough

Study Results

Participant Flow

Recruitment Details	Study was conducted at 4 centers in the United Kingdom. Participants who met eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2798745 in each Treatment Period (each 7 days, with a 14-21 day washout). Total duration of participation was 10.5 weeks. Study terminated on grounds of futility
Pre-assignment Detail	A total of 34 participants were screened of which 17 failed screening and 17 participants were included in the study.

Arm/Group Title	Placebo/GSK2798745	GSK2798745/Placebo
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Period Title: Treatment Period 1 (Up to 7 Days)
STARTED	9	8
COMPLETED	9	8
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (Up to 7 Days)
STARTED	9	8
COMPLETED	8	8
NOT COMPLETED	1	0
Period Title: Treatment Period 1 (Up to 7 Days)
STARTED	8	8
COMPLETED	7	8
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All participants who were randomized to either of the two treatment sequences Placebo/GSK2798745 and GSK2798745/Placebo and received GSK2798745 and placebo in either Treatment period 1 or 2 were included. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Overall Participants	17
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.0 (9.85)
Sex: Female, Male (Count of Participants)
Female	15 88.2%
Male	2 11.8%
Race/Ethnicity, Customized (Number) [Number]
Asian-Japanese/East Asian (EA)/South EA Heritage	1 5.9%
White	16 94.1%

Outcome Measures

1. Primary Outcome

Title	Total Cough Counts During Day Time Hours Following 7-days of Dosing
Description	Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Time Frame	Up to 10 hours post-dose on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Median (95% Confidence Interval) [Cough counts]	180.570	241.105

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2798745
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.336
	Confidence Interval	(2-Sided) 90%; 0.965 to 1.847
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.

2. Secondary Outcome

Title	Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.
Time Frame	Up to 45 days

Outcome Measure Data

Analysis Population Description

All Subjects Population.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	16
Any AE	9 52.9%	11 NaN
Any SAE	0 0%	0 NaN

3. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)
Description	Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	14
ALP	1.8 (9.28)	-3.1 (6.75)
ALT	0.2 (2.31)	-0.2 (5.32)
AST	-0.6 (3.69)	-0.5 (2.65)
CK	-3.0 (21.71)	-12.1 (52.12)

4. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 for each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	14
Direct bilirubin	0.1 (1.11)	0.0 (0.78)
Total bilirubin	-0.4 (3.41)	-0.4 (3.25)
Creatinine	0.31 (6.458)	1.70 (4.031)

5. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea
Description	Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	14
Calcium	0.011 (0.0588)	0.019 (0.0782)
Glucose	-0.22 (1.234)	-0.06 (0.956)
Potassium	0.09 (0.299)	0.09 (0.270)
Sodium	0.2 (1.44)	-0.1 (1.46)
Urea	0.18 (0.683)	-0.36 (0.908)

6. Secondary Outcome

Title	Change From Baseline Values for Clinical Chemistry Parameter: Total Protein
Description	Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	14
Mean (Standard Deviation) [Grams per liter]	1.2 (2.65)	0.9 (2.53)

7. Secondary Outcome

Title	Number of Participants With Abnormal Values of Cardiac Troponin
Description	Cardiac troponin values was measured in participants.
Time Frame	Up to 45 days

Outcome Measure Data

Analysis Population Description

All Subjects Population.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	16
Count of Participants [Participants]	NA NaN	NA NaN

8. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Description	Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Basophils	0.005 (0.0250)	-0.005 (0.0316)
Eosinophils	-0.005 (0.0400)	-0.007 (0.0758)
Lymphocytes	0.019 (0.3065)	-0.002 (0.2608)
Monocytes	-0.012 (0.1110)	0.027 (0.1012)
Total neutrophils	0.186 (0.5817)	0.064 (1.0102)
Platelet count	6.8 (13.57)	6.9 (19.76)
WBC count	0.20 (0.614)	0.09 (1.276)

9. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 for each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Grams per liter]	0.5 (2.29)	0.5 (3.52)

10. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Percentage of red blood cells in blood]	0.0020 (0.01009)	0.0029 (0.00979)

11. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Description	Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 for each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Picograms]	-0.07 (0.377)	-0.09 (0.442)

12. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)
Description	Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Femtoliters]	-0.1 (2.01)	-0.1 (1.53)

13. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count
Description	Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 for each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Tera units per liter]	0.04 (0.112)	0.03 (0.103)

14. Secondary Outcome

Title	Change From Baseline Values for Hematology Parameter: Reticulocytes
Description	Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (Day -1) and Day 8 for each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Percentage of reticulocytes in blood]	-0.0002 (0.00300)	-0.0002 (0.00260)

15. Secondary Outcome

Title	Number of Participants With Abnormal Urinalysis Data
Description	Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.
Time Frame	Up to Day 8

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Count of Participants [Participants]	4 23.5%	2 NaN

16. Secondary Outcome

Title	Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Description	Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
DBP	-0.2 (8.59)	-0.5 (13.07)
SBP	1.6 (12.65)	0.9 (20.10)

17. Secondary Outcome

Title	Change From Baseline in Temperature
Description	Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Degrees Celsius]	0.02 (0.635)	-0.05 (0.331)

18. Secondary Outcome

Title	Change From Baseline in Heart Rate
Description	Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Time Frame	Baseline (pre-dose on Day 1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	15
Mean (Standard Deviation) [Beats per minute]	0.6 (8.65)	-1.3 (12.09)

19. Secondary Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Description	Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.
Time Frame	Baseline (pre-dose on Day 1) and Day 8 of each treatment period

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title).

Arm/Group Title	Placebo	GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.	Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
Measure Participants	17	16
Day 1 pre-dose, not clinically significant,n=17,16	2 11.8%	1 NaN
Day 1 pre-dose, clinically significant, n=17,16	0 0%	0 NaN
Day 8, not clinically significant, n=17,15	2 11.8%	1 NaN
Day 8, clinically significant, n=17,15	0 0%	1 NaN

Adverse Events

Time Frame	AEs and SAEs were collected from the start of the treatment up to 45 days
Adverse Event Reporting Description	AEs and SAEs were collected for All Subjects population
Arm/Group Title	Placebo		GSK2798745
Arm/Group Description	Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.		Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
All Cause Mortality
	Placebo		GSK2798745
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Serious Adverse Events
	Placebo		GSK2798745
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		GSK2798745
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/17 (52.9%)		11/16 (68.8%)
Cardiac disorders
Sinus bradycardia	0/17 (0%)	0	1/16 (6.3%)	1
Ear and labyrinth disorders
Ear pain	1/17 (5.9%)	1	0/16 (0%)	0
Ear pruritus	0/17 (0%)	0	1/16 (6.3%)	1
Hypoacusis	0/17 (0%)	0	1/16 (6.3%)	1
Tinnitus	0/17 (0%)	0	1/16 (6.3%)	1
Eye disorders
Visual impairment	1/17 (5.9%)	1	1/16 (6.3%)	1
Eye pain	1/17 (5.9%)	1	0/16 (0%)	0
Gastrointestinal disorders
Diarrhoea	2/17 (11.8%)	2	1/16 (6.3%)	1
Vomiting	1/17 (5.9%)	1	1/16 (6.3%)	1
Dyspepsia	1/17 (5.9%)	1	0/16 (0%)	0
Gastroenteritis	0/17 (0%)	0	1/16 (6.3%)	1
Irritable bowel syndrome	0/17 (0%)	0	1/16 (6.3%)	1
Toothache	0/17 (0%)	0	1/16 (6.3%)	1
General disorders
Fatigue	1/17 (5.9%)	1	2/16 (12.5%)	2
Feeling cold	1/17 (5.9%)	1	0/16 (0%)	0
Suprapubic pain	0/17 (0%)	0	1/16 (6.3%)	1
Infections and infestations
Oral herpes	1/17 (5.9%)	1	0/16 (0%)	0
Upper respiratory tract infection	1/17 (5.9%)	1	0/16 (0%)	0
Injury, poisoning and procedural complications
Contusion	1/17 (5.9%)	1	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/17 (0%)	0	1/16 (6.3%)	1
Muscle spasms	0/17 (0%)	0	1/16 (6.3%)	1
Musculoskeletal pain	1/17 (5.9%)	1	0/16 (0%)	0
Myalgia	0/17 (0%)	0	1/16 (6.3%)	1
Nervous system disorders
Headache	3/17 (17.6%)	3	7/16 (43.8%)	7
Lethargy	1/17 (5.9%)	1	0/16 (0%)	0
Migraine	1/17 (5.9%)	1	0/16 (0%)	0
Psychiatric disorders
Sleep disorder	1/17 (5.9%)	1	0/16 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	2/17 (11.8%)	2	0/16 (0%)	0
Nasal pruritus	0/17 (0%)	0	1/16 (6.3%)	1
Productive cough	1/17 (5.9%)	1	0/16 (0%)	0
Rhinorrhoea	0/17 (0%)	0	1/16 (6.3%)	1
Sneezing	0/17 (0%)	0	1/16 (6.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.