Trial Outcomes & Findings for Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis (NCT NCT01036022)

Last Updated: 2017-12-18

Results Overview

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalized ratio \>1.5.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

Up to Week 6

Results posted on

2017-12-18

Participant Flow

The study was conducted at 21 centres in Europe and 5 centres in Canada from 15 September 2009 to 29 July 2012.

A total of 78 participants with mild-moderately active ulcerative colitis not limited to the rectum were randomized in the study to receive oral dose of 4 dose levels (10 milligram \[mg\], 30 mg, 100 mg and 300 mg) of GSK1399686, asacol or placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules three times a day (TID) as directed by the investigator for Week 1 to Week 6. Topical 5-aminosalicylic acid (5-ASA) preparation was used as a rescue therapy.	GSK1399686 10 mg Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Overall Study STARTED	15	11	12	12	12	16
Overall Study COMPLETED	13	7	8	10	9	13
Overall Study NOT COMPLETED	2	4	4	2	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules three times a day (TID) as directed by the investigator for Week 1 to Week 6. Topical 5-aminosalicylic acid (5-ASA) preparation was used as a rescue therapy.	GSK1399686 10 mg Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Overall Study Adverse Event	1	3	2	1	0	2
Overall Study Lack of Efficacy	1	1	1	0	1	1
Overall Study Physician Decision	0	0	1	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	2	0

Baseline Characteristics

Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Total n=78 Participants Total of all reporting groups
Age, Continuous	43.0 Years STANDARD_DEVIATION 13.56 • n=5 Participants	51.9 Years STANDARD_DEVIATION 9.59 • n=7 Participants	53.4 Years STANDARD_DEVIATION 13.53 • n=5 Participants	39.0 Years STANDARD_DEVIATION 11.17 • n=4 Participants	42.0 Years STANDARD_DEVIATION 13.99 • n=21 Participants	47.8 Years STANDARD_DEVIATION 13.34 • n=8 Participants	46.1 Years STANDARD_DEVIATION 13.34 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=8 Participants	24 Participants n=8 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	54 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=8 Participants	71 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to Week 6

Population: Intent-To-Treat (ITT) Population was defined as all participants who were randomized to treatment, who received at least one dose of study medication and who had at least one valid post dose assessment.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) Any AE	10 Participants	7 Participants	9 Participants	6 Participants	5 Participants	12 Participants
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) Any SAE	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Normal reference range for clinical chemistry parameters include: alanine amino transferase (ALT) 0-41 international units per liter (IU/L); aspartate amino transferase (AST) 10 - 38 IU/L; alkaline phosphatase 40 - 129 IU/L; gamma glutamyl transferase (GGT) 10 - 66 IU/L; albumin 39 - 48 gram per liter (g/L); total protein 66 - 87 g/L; direct bilirubin 0 - 5.13 micromole per liter (µmol/L); total bilirubin 0 - 17.1 µmol/L; creatinine 61.88 - 106.08 µmol/L; uric acid 202.232 - 416.36 µmol/L; calcium 2.0958 - 2.42015 millimole per liter (mmol/L); cholesterol 2.8446 - 5.9478 mmol/L; chloride 98 - 106 mmol/L; glucose 2.2204 - 11.102 mmol/L; potassium 3.4 - 4.5 mmol/L; magnesium 0.6576 - 1.0686 mmol/L; sodium 0 - 2.26 mmol/L; urea/ blood urea nitrogen (BUN) 0 - 17.85 mmol/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Clinical Chemistry Data Outside the Reference Range Albumin, Week 4, low	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Albumin, Week 6, low	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Calcium, Week 2, high	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Calcium, Week 4, high	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Calcium, Week 6, high	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Glucose, Screening, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Glucose, Week 2, high	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Magnesium, Week 2, high	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Magnesium, Week 2, low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Total Bilirubin, Week 4, high	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range ALT, Week 6, high	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Albumin, Screening, low	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Albumin, Week 2, low	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Potassium, Week 6, high	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Data Outside the Reference Range Sodium, Screening, low	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Normal reference range for clinical chemistry parameters include: basophils 0 - 0.2 giga cells (GI)/L; eosinophils 0 - 0.4 GI/L; lymphocytes 1 - 4.8 GI/L; monocyte 0 - 0.8 GI/L; total neutrophils (total absolute neutrophils count) 1.8 - 7.7 GI/L; platelet count 150 - 400 GI/L; red blood cell count 4.5 - 5.9 GI/L; white blood cell count 3.9 - 10.6 GI/L; hemoglobin 135 - 175 g/L; hematocrit 0.41 - 0.53 ratio; mean corpuscle hemoglobin concentration 310 - 370 g/L; mean corpuscle hemoglobin 26 - 34 picogram (PG); mean corpuscle volume 80 - 100 femtoliter (FL); reticulocytes 0.05 - 0.1 trillion cells (TI)/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Hematology Data Outside the Reference Range Lymphocytes, Screening, low	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Hematology Data Outside the Reference Range Lymphocytes, Week 1, low	0 Participants	1 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Hematology Data Outside the Reference Range Lymphocytes, Week 2, low	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Hematology Data Outside the Reference Range Lymphocytes, Week 4, low	1 Participants	1 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Hematology Data Outside the Reference Range Lymphocytes, Week 6, low	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Hematology Data Outside the Reference Range Platelet count, Screening, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range Platelet count, Week 1, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range Platelet count, Week 2, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range Total ANC, Screening, low	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range WBC, Screening, low	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range Platelet count, Week 4, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Data Outside the Reference Range Platelet count, Week 6, high	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Screening (Day -7 to -1), Week 2, 4 and 6

Population: ITT Population. Only those participants available at the specified time points were analyzed.

The urinalysis parameters included urine occult blood, urine general, glucose, ketones and protein by dipstick analysis. The assessments were done on screening, Week 2, Week 4 and Week 6.The number of participants with results of 0, 0.3, 1, 1+, 1.5, 10, 2+, 3+, 30, 4+, 5+, 55, not rated (NR), positive (pos) and trace is presented.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, 0	3 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, 1+	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, 5+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 2, 0	2 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 2, 2+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 2, 4+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 4, 0	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 4, 2+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 4, 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 4, trace	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 6, 0	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 6, 10	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 6, trace	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Screening, Pos	2 Participants	4 Participants	5 Participants	2 Participants	2 Participants	4 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 2, Pos	3 Participants	2 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 4, NR	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 6, Pos	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Screening, 0	3 Participants	0 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Week 6, 0	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Week 6, Pos	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Screening, 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 2, 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 2, Pos	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 2, Trace	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 4, 0	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 6, Trace	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Screening, 0	3 Participants	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Screening, 0.3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Screening, Pos	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Screening, Trace	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 2, 0	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 2, Pos	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 2, Trace	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 4, 0	3 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 4, 30	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 4, Trace	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 6, 0	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 6, 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 6, Pos	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 6, Trace	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, Pos	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Screening, Trace	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 2, Pos	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Occult Blood, Week 2, trace	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Screening, NR	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 2, NR	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 4, Pos	3 Participants	2 Participants	4 Participants	2 Participants	2 Participants	3 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results General, Week 6, NR	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Screening, 55	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Screening, Pos	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Week 2, 0	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Week 2, Pos	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Glucose, Week 4, 0	3 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Screening, 0	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Screening, Pos	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Screening, Trace	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 2, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 4, 1.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 6, 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Ketones, Week 6, 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 4, 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants of Abnormal Urinalysis Dipstick Results Protein, Week 4, Pos	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Screening (Day -7 to -1), Week 2, 4 and 6

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Vital signs assessment included systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate (HR). Criteria for vital sign values meeting PCI included: SBP \< 85 and \> 160 millimeter of mercury (mmHg); DBP \< 45 and \> 100 mmHg and HR \< 40 and \> 110 beats per minute (bpm). The assessments were done on screening, Week 2, Week 4 and Week 6. The participants with values higher and lower than the PCI range is presented. Only those parameters for which at least one value of PCI was reported at any visit are summarized.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) SBP, Screening, > PCI range	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) SBP, Week 2, > PCI range	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) SBP, Week 4, > PCI range	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) DBP, Screening, > PCI range	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) HR, Week 6, > PCI range	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) SBP, Week 6, > PCI range	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) DBP, Week 4, > PCI range	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) DBP, Week 6, > PCI range	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Screening (Day -7 to -1), Week 2, 4 and 6

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, and QTc intervals. Criteria for ECG parameter values meeting PCI included absolute QTc interval \>500 millisecond (msec); increase from Baseline QTc \>60 msec; PR interval \<110 and \>220 msec; QRS interval \<75 and \>110 msec. Only those participants for whom at least one value of abnormal clinically significant or abnormal not clinically significant ECG findings were reported at any visit are summarized.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Abnormal Electrocardiography (ECG) Findings Not significant, Screening	2 Participants	3 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Electrocardiography (ECG) Findings Not significant, Week 2	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Electrocardiography (ECG) Findings Not significant, Week 4	4 Participants	2 Participants	4 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Electrocardiography (ECG) Findings Not significant, Week 6	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants	5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1, pre dose) and Week 4

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Treatment effects was assessed using a low-dose ACTH stimulation test which was performed on Day 1 pre dose (Baseline) and at Week 4 visit. A blood sample for plasma cortisol was taken immediately, before and 30 minutes after an intravenous injection of 1 microgram (μg). tetracosactide acetate, a synthetic peptide displaying the same physiological properties as ACTH. The change from morning basal cortisol was calculated for Day 1 pre-dose (ACTH1) and Week 4 (ACTH2) using the equation: ACTH1 = Day 1 post ACTH - Day 1 pre ACTH; ACTH2 = Week 4 post ACTH - Week 4 pre ACTH. The change from morning basal cortisol between Week 4 and Day 1 (ACTH effect) was calculated as : ACTH effect = ACTH2 - ACTH1. The difference in morning basal cortisol between Week 4 and Day 1 (ACTH morning) was calculated as:- ACTH morning = Week 4 pre ACTH - Day 1 pre ACTH. Adrenocorticol function was classed as normal if the change from post ACTH to pre ACTH (using ACTH1 and ACTH2) was \>= 200 nanomoles per liter.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline ACTH effect	96.1 Nanomoles per liter Standard Error 103.99	-29.4 Nanomoles per liter Standard Error 141.71	-181.8 Nanomoles per liter Standard Error 118.57	217.8 Nanomoles per liter Standard Error 113.05	22.6 Nanomoles per liter Standard Error 124.98	-152.4 Nanomoles per liter Standard Error 103.99
Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline ACTH 1	180.1 Nanomoles per liter Standard Error 68.48	105.2 Nanomoles per liter Standard Error 79.96	304.3 Nanomoles per liter Standard Error 76.56	-4.9 Nanomoles per liter Standard Error 76.56	310.5 Nanomoles per liter Standard Error 76.56	312.8 Nanomoles per liter Standard Error 66.30
Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline ACTH 2	243.1 Nanomoles per liter Standard Error 81.06	152.7 Nanomoles per liter Standard Error 110.47	167.6 Nanomoles per liter Standard Error 92.42	188.6 Nanomoles per liter Standard Error 88.12	307.8 Nanomoles per liter Standard Error 97.42	143.4 Nanomoles per liter Standard Error 81.06
Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline ACTH morning	-48.8 Nanomoles per liter Standard Error 64.95	-16.6 Nanomoles per liter Standard Error 88.51	116.5 Nanomoles per liter Standard Error 74.05	-202.2 Nanomoles per liter Standard Error 70.60	-44.1 Nanomoles per liter Standard Error 78.06	71.1 Nanomoles per liter Standard Error 64.95

PRIMARY outcome

Timeframe: Week 4

Population: Pharmacokinetic (PK) Population which was defined as the participants in the ITT Population for whom a PK sample was obtained and analysed. Only those participants available at the specified time points were analyzed.

The assessment was done on the samples collected from the sigmoid colon and from the rectum obtained within 24 hour after the last dose on Week 4 visit after endoscopic evaluation of respective area for determination of GSK1399686 concentration. Non-quantifiable (NQ) concentration values were imputed as 0.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=12 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose Rectum	0.0222 Nanogram (ng)/mL Standard Deviation 0.05430	3.9594 Nanogram (ng)/mL Standard Deviation 6.78264	4.6149 Nanogram (ng)/mL Standard Deviation 8.77772	22.9187 Nanogram (ng)/mL Standard Deviation 31.33636	—	—
Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose Sigmoid	0.0652 Nanogram (ng)/mL Standard Deviation 0.09284	4.9721 Nanogram (ng)/mL Standard Deviation 7.84369	7.0701 Nanogram (ng)/mL Standard Deviation 12.08217	24.2401 Nanogram (ng)/mL Standard Deviation 19.50441	—	—

SECONDARY outcome

Timeframe: Up to Week 6

Population: ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the electronic case report form (eCRF) without any imputations added.

SSCAI included composite score: bowel frequency during day on a scale of 0-3 defined as 0 was \<= 3, 1= 4 to 6, 2= 7 to 9 and 3 was \> 9, during night on a scale of 0-2 defined as 0= none, 1=1 to 3 and 2 was \>=4, defecation urgency on a scale of 0-3 defined as 0=none, 1=hurry, 2=immediately and 3=incontinence, blood in stool on a scale of 0-3 defined as 0= none, 1= trace, 2= occasionally frank and 3= usually frank, general well being on a scale of 0-4 defined as 0=very well, 1= slightly below par, 2= poor, 3 = very poor and 4= terrible, extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis) on a scale of 0-1 defined as 0= absent, 1= present. The SCCAI score was calculated as a sum of scores for each individual component of the SCCAI. Minimum score 0, maximum score 19. Higher score implied worsening of symptoms. Participants were given a diary to score each component of SCCAI each morning. Average SCCAI scores over last 3 days were used for each Week.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 1	4.3 Score on scale Standard Error 0.58	4.1 Score on scale Standard Error 0.67	5.7 Score on scale Standard Error 0.67	4.8 Score on scale Standard Error 0.67	5.3 Score on scale Standard Error 0.68	4.5 Score on scale Standard Error 0.55
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 3	4.4 Score on scale Standard Error 0.66	4.5 Score on scale Standard Error 0.82	5.4 Score on scale Standard Error 0.76	4.0 Score on scale Standard Error 0.78	5.2 Score on scale Standard Error 0.83	3.9 Score on scale Standard Error 0.63
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 5	3.7 Score on scale Standard Error 0.79	5.0 Score on scale Standard Error 0.98	4.3 Score on scale Standard Error 0.95	3.9 Score on scale Standard Error 0.95	4.2 Score on scale Standard Error 0.98	3.2 Score on scale Standard Error 0.77
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 6	3.9 Score on scale Standard Error 0.79	4.5 Score on scale Standard Error 1.01	4.4 Score on scale Standard Error 0.96	3.7 Score on scale Standard Error 0.95	4.5 Score on scale Standard Error 0.99	3.1 Score on scale Standard Error 0.77
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 2	4.3 Score on scale Standard Error 0.63	4.6 Score on scale Standard Error 0.73	5.2 Score on scale Standard Error 0.73	3.9 Score on scale Standard Error 0.75	5.0 Score on scale Standard Error 0.79	3.7 Score on scale Standard Error 0.60
Mean Simple Clinical Colitis Activity Index (SCCAI) Score Week 4	3.4 Score on scale Standard Error 0.73	4.6 Score on scale Standard Error 0.89	4.6 Score on scale Standard Error 0.85	3.7 Score on scale Standard Error 0.87	4.5 Score on scale Standard Error 0.91	3.8 Score on scale Standard Error 0.70

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.

Participants were defined as clinical responders if the average change from baseline total SCCAI score was \<-2. (i.e. the post dose total SCCAI score was decreased by \>2 points compared to the baseline total SCCAI score). Baseline was defined as the value on Day -1. The change from baseline total SCCAI score was derived by subtracting the baseline value (Day -1) from the individual post-dose values. Participants were defined as in clinical remission if the post dose total SCCAI score was \<3 and baseline SCCAI score was not \<3 (i.e . =\>3).

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 Clinical Remission, Week 6	3 Participants	2 Participants	2 Participants	2 Participants	3 Participants	7 Participants
Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 Clinical Response, Week 4	6 Participants	2 Participants	3 Participants	3 Participants	2 Participants	6 Participants
Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 Clinical Response, Week 6	7 Participants	1 Participants	3 Participants	2 Participants	3 Participants	5 Participants
Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 Clinical Remission, Week 4	4 Participants	2 Participants	1 Participants	4 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Week 6

Population: ITT Population. Data is presented for the participants available at the time of assessment. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.

Time to clinical response was defined as the number of days between first dose of study medication and first day of at least 3 consecutive days with SCCAI score decreased for \>2 points in comparison with baseline (Day -1 value). Time to clinical remission was defined as the number of days between the first dose of study medication and the first day of at least 3 consecutive days with SCCAI score \< 3. Time to clinical response and remission was derived using daily diary data. Participants who did not meet the criteria for clinical response or clinical remission were censored at their last day on study medication.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=8 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=8 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=8 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=9 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=13 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Median Time to Clinical Response and Clinical Remission Clinical remission	41.0 Days Interval 6.0 to 46.0	16.5 Days Interval 4.0 to 45.0	35.0 Days Interval 21.0 to 44.0	20.5 Days Interval 3.0 to 43.0	31.0 Days Interval 2.0 to 45.0	23.0 Days Interval 2.0 to 43.0
Median Time to Clinical Response and Clinical Remission Clinical response	18.0 Days Interval 2.0 to 45.0	16.5 Days Interval 2.0 to 45.0	26.0 Days Interval 8.0 to 44.0	27.5 Days Interval 3.0 to 44.0	13.0 Days Interval 2.0 to 45.0	22.0 Days Interval 1.0 to 44.0

SECONDARY outcome

Timeframe: Up to Week 6

Fecal calprotectin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Calprotectin is a calcium and zinc-binding protein found in neutrophils, monocytes and macrophages. Calprotectin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Calprotectin plays a regulatory role in the inflammatory process and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Fecal Calprotectin Levels Over Time Week 3	829.9 μg/g Geometric Coefficient of Variation 312.94	529.7 μg/g Geometric Coefficient of Variation 305.31	525.4 μg/g Geometric Coefficient of Variation 3600.04	404.5 μg/g Geometric Coefficient of Variation 428.16	700.3 μg/g Geometric Coefficient of Variation 279.46	289.2 μg/g Geometric Coefficient of Variation 220.34
Mean Fecal Calprotectin Levels Over Time Week 4	651.3 μg/g Geometric Coefficient of Variation 169.58	492.2 μg/g Geometric Coefficient of Variation 644.48	431.3 μg/g Geometric Coefficient of Variation 717.39	347.9 μg/g Geometric Coefficient of Variation 842.92	908.9 μg/g Geometric Coefficient of Variation 386.93	376.8 μg/g Geometric Coefficient of Variation 329.51
Mean Fecal Calprotectin Levels Over Time Week 1	1006.0 μg/g Geometric Coefficient of Variation 131.15	553.6 μg/g Geometric Coefficient of Variation 161.17	620.4 μg/g Geometric Coefficient of Variation 380.26	453.5 μg/g Geometric Coefficient of Variation 522.03	1173.2 μg/g Geometric Coefficient of Variation 290.79	464.4 μg/g Geometric Coefficient of Variation 238.45
Mean Fecal Calprotectin Levels Over Time Week 2	729.6 μg/g Geometric Coefficient of Variation 279.89	514.0 μg/g Geometric Coefficient of Variation 274.43	438.8 μg/g Geometric Coefficient of Variation 321.40	303.6 μg/g Geometric Coefficient of Variation 397.20	580.7 μg/g Geometric Coefficient of Variation 259.64	419.3 μg/g Geometric Coefficient of Variation 265.56
Mean Fecal Calprotectin Levels Over Time Week 5	617.5 μg/g Geometric Coefficient of Variation 156.54	246.1 μg/g Geometric Coefficient of Variation 229.54	690.1 μg/g Geometric Coefficient of Variation 1119.97	289.2 μg/g Geometric Coefficient of Variation 524.84	347.7 μg/g Geometric Coefficient of Variation 443.63	211.8 μg/g Geometric Coefficient of Variation 637.18
Mean Fecal Calprotectin Levels Over Time Week 6	728.6 μg/g Geometric Coefficient of Variation 214.08	276.2 μg/g Geometric Coefficient of Variation 587.18	353.7 μg/g Geometric Coefficient of Variation 960.48	142.9 μg/g Geometric Coefficient of Variation 496.46	528.9 μg/g Geometric Coefficient of Variation 184.78	347.4 μg/g Geometric Coefficient of Variation 408.74

SECONDARY outcome

Timeframe: Up to Week 6

Fecal lactoferrin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Lactoferrin is an iron binding glycoprotein that is the major component of the secondary granules of polymorphonuclear neutrophils (but not monocytes and lymphocytes). Lactoferrin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Lactoferrin plays an important role in the innate immunity as a bactericidal and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 Participants Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 Participants Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Fecal Lactoferrin Levels Over Time Week 2	194.7 µg/L Geometric Coefficient of Variation 309.89	133.2 µg/L Geometric Coefficient of Variation 259.95	148.7 µg/L Geometric Coefficient of Variation 294.15	66.9 µg/L Geometric Coefficient of Variation 408.38	150.2 µg/L Geometric Coefficient of Variation 323.83	126.7 µg/L Geometric Coefficient of Variation 368.30
Mean Fecal Lactoferrin Levels Over Time Week 4	166.0 µg/L Geometric Coefficient of Variation 201.21	44.0 µg/L Geometric Coefficient of Variation 104.68	126.4 µg/L Geometric Coefficient of Variation 641.19	78.9 µg/L Geometric Coefficient of Variation 538.99	177.5 µg/L Geometric Coefficient of Variation 485.01	92.9 µg/L Geometric Coefficient of Variation 313.55
Mean Fecal Lactoferrin Levels Over Time Week 1	158.2 µg/L Geometric Coefficient of Variation 300.88	166.1 µg/L Geometric Coefficient of Variation 192.15	269.8 µg/L Geometric Coefficient of Variation 664.28	163.0 µg/L Geometric Coefficient of Variation 215.09	231.2 µg/L Geometric Coefficient of Variation 201.16	175.3 µg/L Geometric Coefficient of Variation 190.41
Mean Fecal Lactoferrin Levels Over Time Week 3	170.0 µg/L Geometric Coefficient of Variation 303.14	76.5 µg/L Geometric Coefficient of Variation 472.44	167.6 µg/L Geometric Coefficient of Variation 440.45	105.8 µg/L Geometric Coefficient of Variation 490.42	241.7 µg/L Geometric Coefficient of Variation 269.59	52.9 µg/L Geometric Coefficient of Variation 231.47
Mean Fecal Lactoferrin Levels Over Time Week 5	138.7 µg/L Geometric Coefficient of Variation 244.59	145.8 µg/L Geometric Coefficient of Variation 420.34	221.8 µg/L Geometric Coefficient of Variation 184.47	47.1 µg/L Geometric Coefficient of Variation 136.45	144.2 µg/L Geometric Coefficient of Variation 276.04	102.0 µg/L Geometric Coefficient of Variation 344.29
Mean Fecal Lactoferrin Levels Over Time Week 6	89.1 µg/L Geometric Coefficient of Variation 524.87	116.9 µg/L Geometric Coefficient of Variation 548.47	207.9 µg/L Geometric Coefficient of Variation 169.80	42.8 µg/L Geometric Coefficient of Variation 261.57	127.3 µg/L Geometric Coefficient of Variation 187.33	80.8 µg/L Geometric Coefficient of Variation 186.07

SECONDARY outcome

Timeframe: Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)

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

Cmax was derived on Day 1 and Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=12 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing Day 28 (Week 4)	0.1627 Nanogram (ng)/mL Geometric Coefficient of Variation 155.5	0.1956 Nanogram (ng)/mL Geometric Coefficient of Variation 485.5	0.6482 Nanogram (ng)/mL Geometric Coefficient of Variation 306.2	5.5953 Nanogram (ng)/mL Geometric Coefficient of Variation 107.6	—	—
Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing Day 1	0.1326 Nanogram (ng)/mL Geometric Coefficient of Variation 189.4	0.3854 Nanogram (ng)/mL Geometric Coefficient of Variation 154.1	1.1309 Nanogram (ng)/mL Geometric Coefficient of Variation 238.1	1.6866 Nanogram (ng)/mL Geometric Coefficient of Variation 602.1	—	—

SECONDARY outcome

Timeframe: Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)

Population: PK Population. Data is presented for the participants available at the time of assessment.

Cτ was derived on Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=9 Participants Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=11 Participants Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=9 Participants Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Pre-dose Trough Concentration at the End of the Dosing Interval (Cτ) on Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing	0.0500 ng/mL Geometric Coefficient of Variation 0.0	0.1294 ng/mL Geometric Coefficient of Variation 178.3	0.4930 ng/mL Geometric Coefficient of Variation 218.0	1.4066 ng/mL Geometric Coefficient of Variation 85.7	—	—

SECONDARY outcome

Timeframe: Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)

Population: PK Population.

Clearance derived from plasma concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK Population.

Volume of distribution derived from concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

GSK1399686 10 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK1399686 30 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

GSK1399686 100 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK1399686 300 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Asacol

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=15 participants at risk Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 participants at risk Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 participants at risk Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Gastrointestinal disorders Colitis ulcerative	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	18.2% 2/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Clostridial infection	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Blood creatine phosphokinase increased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Bronchitis bacterial	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.

Other adverse events

Other adverse events
Measure	Placebo n=15 participants at risk Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 10 mg n=11 participants at risk Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 30 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 100 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	GSK1399686 300 mg n=12 participants at risk Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.	Asacol n=16 participants at risk Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
Infections and infestations Nasopharyngitis	26.7% 4/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	25.0% 3/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	16.7% 2/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	12.5% 2/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Influenza	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Bronchitis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Cystitis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Infections and infestations Respiratory tract infection	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Colitis ulcerative	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	18.2% 2/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Nausea	13.3% 2/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Flatulence	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Gastric disorder	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Pancreatitis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Regurgitation	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Gastrointestinal disorders Vomiting	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Nervous system disorders Headache	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	25.0% 3/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	18.8% 3/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Nervous system disorders Dizziness	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
General disorders Fatigue	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	18.2% 2/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
General disorders Malaise	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	16.7% 2/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
General disorders Chest discomfort	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
General disorders Chills	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
General disorders Pyrexia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	16.7% 2/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Skin and subcutaneous tissue disorders Acne	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Skin and subcutaneous tissue disorders Skin irritation	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Eye disorders Photophobia	13.3% 2/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Eye disorders Conjunctivitis	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Eye disorders Vision blurred	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Alanine aminotransferase increased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Aspartate aminotransferase increased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Blood alkaline phosphatase increased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Blood chloride increased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Gamma- glutamyltransferase	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Serum ferritin decreased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Investigations Weight decreased	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Injury, poisoning and procedural complications Post procedural haemorrhage	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Injury, poisoning and procedural complications Sunburn	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Endocrine disorders Hyperthyroidism	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	9.1% 1/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Immune system disorders Drug hypersensitivity	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Psychiatric disorders Insomnia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	8.3% 1/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.
Vascular disorders Hot flush	0.00% 0/15 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/11 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	0.00% 0/12 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.	6.2% 1/16 • AE's and SAE's were collected from from Screening (Day -7 to -1) to Week 6 (up to 45 days). ITT Population was used.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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