Colitis, Ulcerative
Conditions
Keywords
mesalazine, ulcerative colitis, pharmacokinetics/dynamics, GSK1399686
Brief summary
This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis. The study is designed as a randomized, double-blind, double-dummy, placebo-controlled, sequential dose escalating trial, with an active control (ASACOL) group as internal control. Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with mild-moderately active ulcerative colitis not limited to the rectum, will be included, one for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively. An interim analysis of fecal markers and disease activity data will be performed by the end of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a dose-response relationship) or, in the case of a robust efficacy signal at any dose level previously studied, Cohort 5 (to expand the sample size for given dose level in order to evaluate the efficacy of GSK1399686). The number of patients and randomization allocation ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is initiated upon interim analysis, then a second interim analysis may be performed at the end of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be justifiable.
Interventions
DRUGGSK1399686
Each dose level of GSK1399686 will be subsequently tested in a cohort of approximately 20 patients, who will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female of non-childbearing potential between 18 and 65 years of age inclusive. 2. Presence of mild-to-moderately active ulcerative colitis spread beyond the rectum as evidenced by clinical signs and endoscopy. 3. UCDAI score 4-10 (inclusive) with rectal bleeding score ≥ 1, endoscopy score ≥ 1 and Physician's rating of disease activity \< 3. 4. Body weight \> or = to 50 kg and BMI within the range 18.5-29.9 kg/m2 (inclusive). 5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion criteria
1. History of sensitivity to any component of study medications, history of hypersensitivity to ACTH, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates patient's participation in the study. 2. History of renal sensitivity to 5-ASA or presence of nephritis, nephropathia or renal function impairment. 3. Presence or a history of asthma or presence or history of other serious allergic disorder. 4. Presence or history of chronic liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 5. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. 6. Presence of significant hematologic disorder, or significant bleeding or immune system disorder. 7. QTcB or QTcF \>450 msec; or QTc \>480 msec in patients with Bundle Branch Block, based on an average QTc value of triplicate ECGs, if the first ECG showed an abnormal value. 8. Presence of a significant cardiac, pulmonary, metabolic or infectious disease or mental disorder that, in the opinion of the Investigator, represents an unacceptable safety risk for participation in this trial. 9. History of malignant neoplastic disease within the past 5 years other than localized basal cell skin cancer, squamous cell skin cancer or cancer in situ that has been resected. 10. History of regular alcohol consumption within 6 months of the study or presence of recreational drug abuse or dependence. 11. Presence of infectious colitis as evidenced by stool culture positive for enteric pathogens or positive Clostridium difficile cytotoxin assay. 12. Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings. 13. Bowel surgery within last 12 months. 14. Treatment with oral aminosalicylates at dose ≥ 2.4 g/day and/or with topical aminosalicylates at any dose within 2 weeks prior to Day 1 visit. 15. Treatment with systemic or topical corticosteroids within 4 weeks prior to Day 1 visit. 16. Treatment with TNF-α inhibitors or other biologics within 2 months prior to Day 1 visit. 17. Treatment with immunosuppressants (azathioprine or 6-mercaptopurine), if initiated within 3 months prior to Day 1 visit, or if changed in terms of drug or dose within 3 months prior to Day 1 visit. 18. Regular use of probiotic or prebiotic preparations, if initiated within 4 weeks prior to Day 1 visit. 19. Regular daily use of non-steroidal anti-inflammatory drugs (NSAIDs), except low dose aspirin (325 mg/day) for cardioprotection, within 7 days prior to Day 1 visit. 20. Treatment with medications known to be strong inducers of CYP3A4/5 (e.g. carbamezipine, phenobarbital, phenytoin, rifabutin, rifampin, troglitazone) or regular use of St. John's Wort within 14 days prior to Day 1 visit. 21. Treatment with medications known to be strong inhibitors of CYP3A4/5 (e.g. ketoconazole, itraconazole, fluconazole, mibefradil, clarithromycin, erythromycin, diltiazem, verapamil), or regular use of grapefruit juice within 7 days prior to Day 1 visit. 22. Treatment with medications known to be sensitive CYP3A4 substrates with a narrow therapeutic index (e.g. alfentanil, astemizole, cisapride, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) within 7 days prior to Day 1 visit. 23. Participation in a clinical trial and treatment with an investigational product within the following time period prior to the Day 1 visit: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 24. Prior enrolment in the present trial. For Canadian sites only: 25. Patients with existing gastric or duodenal ulcers. 26. Patients with urinary tract obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Up to Week 6 | 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. |
| Number of Participants With Clinical Chemistry Data Outside the Reference Range | Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6 | 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. |
| Number of Participants With Hematology Data Outside the Reference Range | Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6 | 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. |
| Number of Participants of Abnormal Urinalysis Dipstick Results | Screening (Day -7 to -1), Week 2, 4 and 6 | 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. |
| Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | Screening (Day -7 to -1), Week 2, 4 and 6 | 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. |
| Number of Participants With Abnormal Electrocardiography (ECG) Findings | Screening (Day -7 to -1), Week 2, 4 and 6 | 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. |
| Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | Baseline (Day 1, pre dose) and Week 4 | 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. |
| Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Up to Week 6 | 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. |
| Volume of Distribution Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data | 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) | 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. |
| Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Week 4 and Week 6 | 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). |
| Median Time to Clinical Response and Clinical Remission | Up to Week 6 | 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. |
| Mean Fecal Calprotectin Levels Over Time | 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. |
| Mean Fecal Lactoferrin Levels Over Time | 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. |
| Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing | 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) | 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). |
| 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 | Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose) | 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). |
| Plasma Clearance Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data | 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) | 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. |
Countries
Belgium, Canada, Germany, Norway, Sweden
Participant flow
Recruitment details
The study was conducted at 21 centres in Europe and 5 centres in Canada from 15 September 2009 to 29 July 2012.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy. | 15 |
| 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. | 11 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 16 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Placebo | Total | Asacol | GSK1399686 300 mg | GSK1399686 100 mg | GSK1399686 30 mg | GSK1399686 10 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 13.56 | 46.1 Years STANDARD_DEVIATION 13.34 | 47.8 Years STANDARD_DEVIATION 13.34 | 42.0 Years STANDARD_DEVIATION 13.99 | 39.0 Years STANDARD_DEVIATION 11.17 | 53.4 Years STANDARD_DEVIATION 13.53 | 51.9 Years STANDARD_DEVIATION 9.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 71 Participants | 13 Participants | 11 Participants | 10 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Female | 2 Participants | 24 Participants | 8 Participants | 5 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 13 Participants | 54 Participants | 8 Participants | 7 Participants | 10 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 11 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 16 |
| other Total, other adverse events | 10 / 15 | 6 / 11 | 9 / 12 | 6 / 12 | 5 / 12 | 12 / 16 |
| serious Total, serious adverse events | 1 / 15 | 2 / 11 | 0 / 12 | 0 / 12 | 0 / 12 | 1 / 16 |
Outcome results
Primary
Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Rectum | 0.0222 Nanogram (ng)/mL | Standard Deviation 0.0543 |
| Placebo | 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 |
| GSK1399686 10 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Sigmoid | 4.9721 Nanogram (ng)/mL | Standard Deviation 7.84369 |
| GSK1399686 10 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Rectum | 3.9594 Nanogram (ng)/mL | Standard Deviation 6.78264 |
| GSK1399686 30 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Sigmoid | 7.0701 Nanogram (ng)/mL | Standard Deviation 12.08217 |
| GSK1399686 30 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Rectum | 4.6149 Nanogram (ng)/mL | Standard Deviation 8.77772 |
| GSK1399686 100 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Rectum | 22.9187 Nanogram (ng)/mL | Standard Deviation 31.33636 |
| GSK1399686 100 mg | Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose | Sigmoid | 24.2401 Nanogram (ng)/mL | Standard Deviation 19.50441 |
Primary
Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline
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.
Time frame: Baseline (Day 1, pre dose) and Week 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GSK1399686 10 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH morning | -16.6 Nanomoles per liter | Standard Error 88.51 |
| GSK1399686 10 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 1 | 105.2 Nanomoles per liter | Standard Error 79.96 |
| GSK1399686 10 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 2 | 152.7 Nanomoles per liter | Standard Error 110.47 |
| GSK1399686 10 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH effect | -29.4 Nanomoles per liter | Standard Error 141.71 |
| GSK1399686 30 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH morning | 116.5 Nanomoles per liter | Standard Error 74.05 |
| GSK1399686 30 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH effect | -181.8 Nanomoles per liter | Standard Error 118.57 |
| GSK1399686 30 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 1 | 304.3 Nanomoles per liter | Standard Error 76.56 |
| GSK1399686 30 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 2 | 167.6 Nanomoles per liter | Standard Error 92.42 |
| GSK1399686 100 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH morning | -202.2 Nanomoles per liter | Standard Error 70.6 |
| GSK1399686 100 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 2 | 188.6 Nanomoles per liter | Standard Error 88.12 |
| GSK1399686 100 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH effect | 217.8 Nanomoles per liter | Standard Error 113.05 |
| GSK1399686 100 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 1 | -4.9 Nanomoles per liter | Standard Error 76.56 |
| GSK1399686 300 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 2 | 307.8 Nanomoles per liter | Standard Error 97.42 |
| GSK1399686 300 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH morning | -44.1 Nanomoles per liter | Standard Error 78.06 |
| GSK1399686 300 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH effect | 22.6 Nanomoles per liter | Standard Error 124.98 |
| GSK1399686 300 mg | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 1 | 310.5 Nanomoles per liter | Standard Error 76.56 |
| Asacol | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH morning | 71.1 Nanomoles per liter | Standard Error 64.95 |
| Asacol | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 1 | 312.8 Nanomoles per liter | Standard Error 66.3 |
| Asacol | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH effect | -152.4 Nanomoles per liter | Standard Error 103.99 |
| Asacol | Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline | ACTH 2 | 143.4 Nanomoles per liter | Standard Error 81.06 |
Comparison: Placebo versus GSK1399686 100 mg for ACTH 2p-value: 0.651195% CI: [-294.2, 185.3]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 300 mg for ACTH 2p-value: 0.611795% CI: [-189.1, 318.5]Mixed Models Analysis
Comparison: Placebo versus Asacol for ACTH 2p-value: 0.388295% CI: [-329.3, 129.9]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 10 mg for ACTH 1p-value: 0.478895% CI: [-284.8, 134.9]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 30 mg for ACTH 1p-value: 0.230995% CI: [-80.6, 328.9]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 100 mg for ACTH 1p-value: 0.075895% CI: [-389.8, 19.7]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 300 mg for ACTH 1p-value: 0.208495% CI: [-74.4, 335.1]Mixed Models Analysis
Comparison: Placebo versus Asacol for ACTH 1p-value: 0.168495% CI: [-57.4, 322.6]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 10 mg for ACTH 2p-value: 0.512295% CI: [-364.7, 184]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 30 mg for ACTH 2p-value: 0.541795% CI: [-321.7, 170.7]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 10 mg for ACTH effectp-value: 0.478195% CI: [-477.5, 226.5]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 30 mg for ACTH effectp-value: 0.083495% CI: [-593.7, 37.9]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 100 mg for ACTH effectp-value: 0.431395% CI: [-185.8, 429.3]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 300 mg for ACTH effectp-value: 0.652895% CI: [-399.1, 252]Mixed Models Analysis
Comparison: Placebo versus Asacol for ACTH effectp-value: 0.096695% CI: [-542.9, 46]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 10 mg for ACTH morningp-value: 0.770495% CI: [-187.6, 252]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 30 mg for ACTH morningp-value: 0.098895% CI: [-32, 362.5]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 100 mg for ACTH morningp-value: 0.115395% CI: [-345.5, 38.7]Mixed Models Analysis
Comparison: Placebo versus GSK1399686 300 mg for ACTH morningp-value: 0.963695% CI: [-198.7, 208]Mixed Models Analysis
Comparison: Placebo versus Asacol for ACTH morningp-value: 0.197295% CI: [-64.1, 303.8]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 10 mg for ACTH 1p-value: 0.049595% CI: [-414.6, -0.5]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 30 mg for ACTH 1p-value: 0.933395% CI: [-210.4, 193.4]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 100 mg for ACTH 1p-value: 0.002595% CI: [-519.6, -115.8]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 300 mg for ACTH 1p-value: 0.982395% CI: [-204.1, 199.6]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 10 mg for ACTH 2p-value: 0.94695% CI: [-265, 283.7]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 30 mg for ACTH 2p-value: 0.844595% CI: [-222, 270.4]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 100 mg for ACTH 2p-value: 0.706995% CI: [-194.5, 285]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 300 mg for ACTH 2p-value: 0.199895% CI: [-89.4, 418.2]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 10 mg for ACTH effectp-value: 0.487195% CI: [-229, 474.9]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 30 mg for ACTH effectp-value: 0.852795% CI: [-345.2, 286.4]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 100 mg for ACTH effectp-value: 0.019295% CI: [62.6, 677.8]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 300 mg for ACTH effectp-value: 0.286595% CI: [-150.6, 500.5]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 10 mg for ACTH morningp-value: 0.427995% CI: [-307.5, 132.2]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 30 mg for ACTH morningp-value: 0.646495% CI: [-151.8, 242.7]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 100 mg for ACTH morningp-value: 0.006195% CI: [-465.4, -81.2]Mixed Models Analysis
Comparison: Asacol versus GSK1399686 300 mg for ACTH morningp-value: 0.261495% CI: [-318.5, 88.1]Mixed Models Analysis
Primary
Number of Participants of Abnormal Urinalysis Dipstick Results
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.
Time frame: Screening (Day -7 to -1), Week 2, 4 and 6
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 1 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 2 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 3 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 0 Participants |
| Placebo | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 3 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 1 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 2 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 2 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 4 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 1 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 3 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 1 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 1 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 2 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 3 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 0 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 1 Participants |
| GSK1399686 10 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 3 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 3 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 5 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 2 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 4 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 3 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 0 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 1 Participants |
| GSK1399686 30 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 2 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 2 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 1 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 0 Participants |
| GSK1399686 100 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 2 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 2 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 2 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 2 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 0 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 1 Participants |
| GSK1399686 300 mg | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 1+ | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, NR | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 2+ | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, Trace | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Trace | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 0 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 1+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, 3+ | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, 3+ | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 1+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 6, 0 | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 0 | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 2+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 4, trace | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 0 | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 4, 0 | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Trace | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 2+ | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 6, 0 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0.3 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, 5+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, 10 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Pos | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 1.5 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Trace | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 6, trace | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 4, Pos | 3 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, NR | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Pos | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 2, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, NR | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 4, 0 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Week 2, 0 | 2 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, 55 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 4+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Screening, Pos | 4 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 30 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Trace | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Pos | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 6, Pos | 3 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Screening, Trace | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, NR | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Screening, Trace | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, 0 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 6, 1 | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Glucose, Screening, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Week 4, 2+ | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | General, Week 2, Pos | 3 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Ketones, Week 2, Pos | 0 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, trace | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Occult Blood, Week 2, 0 | 1 Participants |
| Asacol | Number of Participants of Abnormal Urinalysis Dipstick Results | Protein, Screening, Trace | 1 Participants |
Primary
Number of Participants With Abnormal Electrocardiography (ECG) Findings
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.
Time frame: Screening (Day -7 to -1), Week 2, 4 and 6
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 2 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 1 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 2 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 4 Participants |
| GSK1399686 10 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 2 Participants |
| GSK1399686 10 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 3 Participants |
| GSK1399686 10 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 2 Participants |
| GSK1399686 10 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 4 Participants |
| GSK1399686 100 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 2 Participants |
| GSK1399686 100 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 2 Participants |
| GSK1399686 100 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 1 Participants |
| Asacol | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 4 | 3 Participants |
| Asacol | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 2 | 2 Participants |
| Asacol | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Screening | 2 Participants |
| Asacol | Number of Participants With Abnormal Electrocardiography (ECG) Findings | Not significant, Week 6 | 5 Participants |
Primary
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 10 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 7 Participants |
| GSK1399686 10 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 9 Participants |
| GSK1399686 30 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 6 Participants |
| GSK1399686 100 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 5 Participants |
| GSK1399686 300 mg | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Asacol | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any AE | 12 Participants |
| Asacol | Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) | Any SAE | 1 Participants |
Primary
Number of Participants With Clinical Chemistry Data Outside the Reference Range
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Screening, low | 1 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 4, low | 1 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | ALT, Week 6, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Total Bilirubin, Week 4, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 6, low | 1 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Sodium, Screening, low | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Screening, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 2, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Potassium, Week 6, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, low | 1 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 4, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Magnesium, Week 2, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Glucose, Week 2, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Calcium, Week 6, high | 0 Participants |
| Asacol | Number of Participants With Clinical Chemistry Data Outside the Reference Range | Albumin, Week 2, low | 0 Participants |
Primary
Number of Participants With Hematology Data Outside the Reference Range
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 1 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 1 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 1 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 0 Participants |
| Placebo | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 3 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 3 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 2 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 4 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 3 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 3 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 2 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 4, low | 1 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 1, low | 3 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 6, low | 1 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Total ANC, Screening, low | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 1, high | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Screening, high | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | WBC, Screening, low | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 2, high | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Screening, low | 3 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 4, high | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Platelet count, Week 6, high | 0 Participants |
| Asacol | Number of Participants With Hematology Data Outside the Reference Range | Lymphocytes, Week 2, low | 1 Participants |
Primary
Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI)
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.
Time frame: Screening (Day -7 to -1), Week 2, 4 and 6
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 0 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 0 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 0 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 0 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 1 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 0 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 1 Participants |
| Placebo | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 1 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 0 Participants |
| GSK1399686 10 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 0 Participants |
| GSK1399686 30 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 2 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 1 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 0 Participants |
| GSK1399686 100 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 1 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 0 Participants |
| GSK1399686 300 mg | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | HR, Week 6, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Screening, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 4, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 6, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 4, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Week 2, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | DBP, Week 6, > PCI range | 0 Participants |
| Asacol | Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI) | SBP, Screening, > PCI range | 0 Participants |
Secondary
Mean Fecal Calprotectin Levels Over Time
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.
Time frame: 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 eCRF without any imputations added.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 1 | 1006.0 μg/g | Geometric Coefficient of Variation 131.15 |
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 4 | 651.3 μg/g | Geometric Coefficient of Variation 169.58 |
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 5 | 617.5 μg/g | Geometric Coefficient of Variation 156.54 |
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 6 | 728.6 μg/g | Geometric Coefficient of Variation 214.08 |
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 2 | 729.6 μg/g | Geometric Coefficient of Variation 279.89 |
| Placebo | Mean Fecal Calprotectin Levels Over Time | Week 3 | 829.9 μg/g | Geometric Coefficient of Variation 312.94 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 3 | 529.7 μg/g | Geometric Coefficient of Variation 305.31 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 6 | 276.2 μg/g | Geometric Coefficient of Variation 587.18 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 2 | 514.0 μg/g | Geometric Coefficient of Variation 274.43 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 5 | 246.1 μg/g | Geometric Coefficient of Variation 229.54 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 4 | 492.2 μg/g | Geometric Coefficient of Variation 644.48 |
| GSK1399686 10 mg | Mean Fecal Calprotectin Levels Over Time | Week 1 | 553.6 μg/g | Geometric Coefficient of Variation 161.17 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 4 | 431.3 μg/g | Geometric Coefficient of Variation 717.39 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 1 | 620.4 μg/g | Geometric Coefficient of Variation 380.26 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 3 | 525.4 μg/g | Geometric Coefficient of Variation 3600.04 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 6 | 353.7 μg/g | Geometric Coefficient of Variation 960.48 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 5 | 690.1 μg/g | Geometric Coefficient of Variation 1119.97 |
| GSK1399686 30 mg | Mean Fecal Calprotectin Levels Over Time | Week 2 | 438.8 μg/g | Geometric Coefficient of Variation 321.4 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 2 | 303.6 μg/g | Geometric Coefficient of Variation 397.2 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 4 | 347.9 μg/g | Geometric Coefficient of Variation 842.92 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 3 | 404.5 μg/g | Geometric Coefficient of Variation 428.16 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 5 | 289.2 μg/g | Geometric Coefficient of Variation 524.84 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 6 | 142.9 μg/g | Geometric Coefficient of Variation 496.46 |
| GSK1399686 100 mg | Mean Fecal Calprotectin Levels Over Time | Week 1 | 453.5 μg/g | Geometric Coefficient of Variation 522.03 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 1 | 1173.2 μg/g | Geometric Coefficient of Variation 290.79 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 2 | 580.7 μg/g | Geometric Coefficient of Variation 259.64 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 6 | 528.9 μg/g | Geometric Coefficient of Variation 184.78 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 3 | 700.3 μg/g | Geometric Coefficient of Variation 279.46 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 5 | 347.7 μg/g | Geometric Coefficient of Variation 443.63 |
| GSK1399686 300 mg | Mean Fecal Calprotectin Levels Over Time | Week 4 | 908.9 μg/g | Geometric Coefficient of Variation 386.93 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 1 | 464.4 μg/g | Geometric Coefficient of Variation 238.45 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 3 | 289.2 μg/g | Geometric Coefficient of Variation 220.34 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 6 | 347.4 μg/g | Geometric Coefficient of Variation 408.74 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 5 | 211.8 μg/g | Geometric Coefficient of Variation 637.18 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 2 | 419.3 μg/g | Geometric Coefficient of Variation 265.56 |
| Asacol | Mean Fecal Calprotectin Levels Over Time | Week 4 | 376.8 μg/g | Geometric Coefficient of Variation 329.51 |
Comparison: Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels95% CI: [0.24, 2.39]
Comparison: Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels95% CI: [0.21, 1.92]
Comparison: Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels95% CI: [0.26, 2.48]
Comparison: Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels95% CI: [0.27, 2.68]
Comparison: Placebo versus Asacol for Week 1 fecal calprotectin levels95% CI: [0.23, 1.81]
Comparison: Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels95% CI: [0.26, 2.73]
Comparison: Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels95% CI: [0.18, 1.68]
Comparison: Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels95% CI: [0.21, 2.18]
Comparison: Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels95% CI: [0.19, 2.03]
Comparison: Placebo versus Asacol for Week 2 fecal calprotectin levels95% CI: [0.22, 1.9]
Comparison: Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels95% CI: [0.28, 4.09]
Comparison: Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels95% CI: [0.23, 2.43]
Comparison: Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels95% CI: [0.18, 2.08]
Comparison: Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels95% CI: [0.17, 2.08]
Comparison: Placebo versus Asacol for Week 3 fecal calprotectin levels95% CI: [0.15, 1.32]
Comparison: Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels95% CI: [0.33, 5.04]
Comparison: Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels95% CI: [0.2, 2.02]
Comparison: Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels95% CI: [0.29, 3.23]
Comparison: Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels95% CI: [0.39, 4.72]
Comparison: Placebo versus Asacol for Week 4 fecal calprotectin levels95% CI: [0.28, 2.42]
Comparison: Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels95% CI: [0.14, 2.66]
Comparison: Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels95% CI: [0.35, 4.38]
Comparison: Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels95% CI: [0.2, 2.47]
Comparison: Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels95% CI: [0.11, 1.46]
Comparison: Placebo versus Asacol for Week 5 fecal calprotectin levels95% CI: [0.15, 1.48]
Comparison: Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels95% CI: [0.13, 3.39]
Comparison: Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels95% CI: [0.11, 1.84]
Comparison: Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels95% CI: [0.09, 1.48]
Comparison: Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels95% CI: [0.19, 2.99]
Comparison: Placebo versus Asacol for Week 6 fecal calprotectin levels95% CI: [0.21, 2.49]
Secondary
Mean Fecal Lactoferrin Levels Over Time
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.
Time frame: 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 eCRF without any imputations added.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 166.0 µg/L | Geometric Coefficient of Variation 201.21 |
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 194.7 µg/L | Geometric Coefficient of Variation 309.89 |
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 158.2 µg/L | Geometric Coefficient of Variation 300.88 |
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 89.1 µg/L | Geometric Coefficient of Variation 524.87 |
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 138.7 µg/L | Geometric Coefficient of Variation 244.59 |
| Placebo | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 170.0 µg/L | Geometric Coefficient of Variation 303.14 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 76.5 µg/L | Geometric Coefficient of Variation 472.44 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 116.9 µg/L | Geometric Coefficient of Variation 548.47 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 145.8 µg/L | Geometric Coefficient of Variation 420.34 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 166.1 µg/L | Geometric Coefficient of Variation 192.15 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 44.0 µg/L | Geometric Coefficient of Variation 104.68 |
| GSK1399686 10 mg | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 133.2 µg/L | Geometric Coefficient of Variation 259.95 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 269.8 µg/L | Geometric Coefficient of Variation 664.28 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 126.4 µg/L | Geometric Coefficient of Variation 641.19 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 221.8 µg/L | Geometric Coefficient of Variation 184.47 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 148.7 µg/L | Geometric Coefficient of Variation 294.15 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 167.6 µg/L | Geometric Coefficient of Variation 440.45 |
| GSK1399686 30 mg | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 207.9 µg/L | Geometric Coefficient of Variation 169.8 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 78.9 µg/L | Geometric Coefficient of Variation 538.99 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 66.9 µg/L | Geometric Coefficient of Variation 408.38 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 47.1 µg/L | Geometric Coefficient of Variation 136.45 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 42.8 µg/L | Geometric Coefficient of Variation 261.57 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 163.0 µg/L | Geometric Coefficient of Variation 215.09 |
| GSK1399686 100 mg | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 105.8 µg/L | Geometric Coefficient of Variation 490.42 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 144.2 µg/L | Geometric Coefficient of Variation 276.04 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 127.3 µg/L | Geometric Coefficient of Variation 187.33 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 241.7 µg/L | Geometric Coefficient of Variation 269.59 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 177.5 µg/L | Geometric Coefficient of Variation 485.01 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 231.2 µg/L | Geometric Coefficient of Variation 201.16 |
| GSK1399686 300 mg | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 150.2 µg/L | Geometric Coefficient of Variation 323.83 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 2 | 126.7 µg/L | Geometric Coefficient of Variation 368.3 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 4 | 92.9 µg/L | Geometric Coefficient of Variation 313.55 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 6 | 80.8 µg/L | Geometric Coefficient of Variation 186.07 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 1 | 175.3 µg/L | Geometric Coefficient of Variation 190.41 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 5 | 102.0 µg/L | Geometric Coefficient of Variation 344.29 |
| Asacol | Mean Fecal Lactoferrin Levels Over Time | Week 3 | 52.9 µg/L | Geometric Coefficient of Variation 231.47 |
Comparison: Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels95% CI: [0.42, 3.38]
Comparison: Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels95% CI: [0.5, 3.65]
Comparison: Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels95% CI: [0.45, 3.47]
Comparison: Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels95% CI: [0.44, 3.59]
Comparison: Placebo versus Asacol for Week 1 fecal lactoferrin levels95% CI: [0.5, 3.28]
Comparison: Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels95% CI: [0.26, 2.19]
Comparison: Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels95% CI: [0.22, 1.63]
Comparison: Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels95% CI: [0.12, 1]
Comparison: Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels95% CI: [0.31, 2.77]
Comparison: Placebo versus Asacol for Week 2 fecal lactoferrin levels95% CI: [0.26, 1.87]
Comparison: Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels95% CI: [0.15, 1.84]
Comparison: Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels95% CI: [0.32, 2.87]
Comparison: Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels95% CI: [0.17, 1.56]
Comparison: Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels95% CI: [0.45, 4.46]
Comparison: Placebo versus Asacol for Week 3 fecal lactoferrin levels95% CI: [0.14, 1.01]
Comparison: Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels95% CI: [0.1, 1.15]
Comparison: Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels95% CI: [0.23, 2.03]
Comparison: Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels95% CI: [0.19, 1.68]
Comparison: Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels95% CI: [0.38, 3.7]
Comparison: Placebo versus Asacol for Week 4 fecal lactoferrin levels95% CI: [0.26, 1.89]
Comparison: Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels95% CI: [0.27, 4.07]
Comparison: Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels95% CI: [0.46, 4.73]
Comparison: Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels95% CI: [0.11, 1.02]
Comparison: Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels95% CI: [0.36, 3.73]
Comparison: Placebo versus Asacol for Week 5 fecal lactoferrin levels95% CI: [0.29, 2.33]
Comparison: Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels95% CI: [0.31, 6.59]
Comparison: Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels95% CI: [0.54, 9.04]
Comparison: Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels95% CI: [0.11, 1.48]
Comparison: Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels95% CI: [0.46, 5.91]
Comparison: Placebo versus Asacol for Week 6 fecal lactoferrin levels95% CI: [0.27, 2.62]
Secondary
Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing
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).
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| GSK1399686 10 mg | Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing | Day 1 | 0.3854 Nanogram (ng)/mL | Geometric Coefficient of Variation 154.1 |
| GSK1399686 10 mg | 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) | 0.1956 Nanogram (ng)/mL | Geometric Coefficient of Variation 485.5 |
| GSK1399686 30 mg | Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing | Day 1 | 1.1309 Nanogram (ng)/mL | Geometric Coefficient of Variation 238.1 |
| GSK1399686 30 mg | 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) | 0.6482 Nanogram (ng)/mL | Geometric Coefficient of Variation 306.2 |
| GSK1399686 100 mg | 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) | 5.5953 Nanogram (ng)/mL | Geometric Coefficient of Variation 107.6 |
| GSK1399686 100 mg | Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing | Day 1 | 1.6866 Nanogram (ng)/mL | Geometric Coefficient of Variation 602.1 |
Secondary
Mean Simple Clinical Colitis Activity Index (SCCAI) Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 4.4 Score on scale | Standard Error 0.66 |
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 3.4 Score on scale | Standard Error 0.73 |
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 4.3 Score on scale | Standard Error 0.58 |
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 3.7 Score on scale | Standard Error 0.79 |
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 4.3 Score on scale | Standard Error 0.63 |
| Placebo | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 3.9 Score on scale | Standard Error 0.79 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 4.6 Score on scale | Standard Error 0.73 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 4.5 Score on scale | Standard Error 1.01 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 4.5 Score on scale | Standard Error 0.82 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 4.6 Score on scale | Standard Error 0.89 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 4.1 Score on scale | Standard Error 0.67 |
| GSK1399686 10 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 5.0 Score on scale | Standard Error 0.98 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 5.2 Score on scale | Standard Error 0.73 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 4.3 Score on scale | Standard Error 0.95 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 5.7 Score on scale | Standard Error 0.67 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 4.4 Score on scale | Standard Error 0.96 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 5.4 Score on scale | Standard Error 0.76 |
| GSK1399686 30 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 4.6 Score on scale | Standard Error 0.85 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 3.7 Score on scale | Standard Error 0.95 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 3.9 Score on scale | Standard Error 0.75 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 4.8 Score on scale | Standard Error 0.67 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 3.9 Score on scale | Standard Error 0.95 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 3.7 Score on scale | Standard Error 0.87 |
| GSK1399686 100 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 4.0 Score on scale | Standard Error 0.78 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 4.5 Score on scale | Standard Error 0.99 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 5.0 Score on scale | Standard Error 0.79 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 5.3 Score on scale | Standard Error 0.68 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 5.2 Score on scale | Standard Error 0.83 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 4.5 Score on scale | Standard Error 0.91 |
| GSK1399686 300 mg | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 4.2 Score on scale | Standard Error 0.98 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 5 | 3.2 Score on scale | Standard Error 0.77 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 4 | 3.8 Score on scale | Standard Error 0.7 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 3 | 3.9 Score on scale | Standard Error 0.63 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 1 | 4.5 Score on scale | Standard Error 0.55 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 6 | 3.1 Score on scale | Standard Error 0.77 |
| Asacol | Mean Simple Clinical Colitis Activity Index (SCCAI) Score | Week 2 | 3.7 Score on scale | Standard Error 0.6 |
Comparison: Placebo versus GSK1399686 10 mg for Week 1 SCCAI scorep-value: 0.755995% CI: [-2, 1.5]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 1 SCCAI scorep-value: 0.123895% CI: [-0.4, 3.2]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 1 SCCAI scorep-value: 0.630295% CI: [-1.3, 2.2]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 1 SCCAI scorep-value: 0.277795% CI: [-0.8, 2.8]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 1 SCCAI scorep-value: 0.806995% CI: [-1.4, 1.8]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 10 mg for Week 2 SCCAI scorep-value: 0.769995% CI: [-1.6, 2.2]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 2 SCCAI scorep-value: 0.386995% CI: [-1.1, 2.8]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 2 SCCAI scorep-value: 0.669595% CI: [-2.4, 1.5]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 2 SCCAI scorep-value: 0.515295% CI: [-1.4, 2.7]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 2 SCCAI scorep-value: 0.450795% CI: [-2.4, 1.1]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 10 mg for Week 3 SCCAI scorep-value: 0.870795% CI: [-1.9, 2.3]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 3 SCCAI scorep-value: 0.291595% CI: [-0.9, 3.1]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 3 SCCAI scorep-value: 0.725195% CI: [-2.4, 1.7]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 3 SCCAI scorep-value: 0.455695% CI: [-1.3, 2.9]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 3 SCCAI scorep-value: 0.66295% CI: [-2.3, 1.4]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 10 mg for Week 4 SCCAI scorep-value: 0.284495% CI: [-1.1, 3.5]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 4 SCCAI scorep-value: 0.279995% CI: [-1, 3.5]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 4 SCCAI scorep-value: 0.765595% CI: [-1.9, 2.6]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 4 SCCAI scorep-value: 0.333295% CI: [-1.2, 3.5]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 4 SCCAI scorep-value: 0.698595% CI: [-1.6, 2.4]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 10 mg for Week 5 SCCAI scorep-value: 0.325695% CI: [-1.3, 3.7]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 5 SCCAI scorep-value: 0.6595% CI: [-1.9, 3]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 5 SCCAI scorep-value: 0.875895% CI: [-2.3, 2.7]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 5 SCCAI scorep-value: 0.729895% CI: [-2.1, 3]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 5 SCCAI scorep-value: 0.596395% CI: [-2.8, 1.6]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 10 mg for Week 6 SCCAI scorep-value: 0.649895% CI: [-2, 3.1]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 30 mg for Week 6 SCCAI scorep-value: 0.706195% CI: [-2, 3]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 100 mg for Week 6 SCCAI scorep-value: 0.854995% CI: [-2.7, 2.3]Repeated measures mixed model
Comparison: Placebo versus GSK1399686 300 mg for Week 6 SCCAI scorep-value: 0.653395% CI: [-2, 3.1]Repeated measures mixed model
Comparison: Placebo versus Asacol for Week 6 SCCAI scorep-value: 0.437895% CI: [-3.1, 1.4]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 1 SCCAI scorep-value: 0.591795% CI: [-2.2, 1.3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 1 SCCAI scorep-value: 0.176495% CI: [-0.5, 2.9]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 1 SCCAI scorep-value: 0.791495% CI: [-1.5, 2]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 1 SCCAI scorep-value: 0.357895% CI: [-0.9, 2.5]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 2 SCCAI scorep-value: 0.324795% CI: [-1, 2.9]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 2 SCCAI scorep-value: 0.115395% CI: [-0.4, 3.4]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 2 SCCAI scorep-value: 0.799595% CI: [-1.7, 2.2]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 2 SCCAI scorep-value: 0.178695% CI: [-0.6, 3.3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 3 SCCAI scorep-value: 0.582495% CI: [-1.5, 2.7]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 3 SCCAI scorep-value: 0.139295% CI: [-0.5, 3.5]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 3 SCCAI scorep-value: 0.966595% CI: [-2, 2.1]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 3 SCCAI scorep-value: 0.245595% CI: [-0.9, 3.3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 4 SCCAI scorep-value: 0.464495% CI: [-1.4, 3.1]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 4 SCCAI scorep-value: 0.456795% CI: [-1.4, 3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 4 SCCAI scorep-value: 0.959495% CI: [-2.3, 2.2]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 4 SCCAI scorep-value: 0.512295% CI: [-1.5, 3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 5 SCCAI scorep-value: 0.149395% CI: [-0.7, 4.3]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 5 SCCAI scorep-value: 0.347895% CI: [-1.3, 3.6]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 5 SCCAI scorep-value: 0.523895% CI: [-1.7, 3.2]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 5 SCCAI scorep-value: 0.409195% CI: [-1.4, 3.5]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 10 mg for Week 6 SCCAI scorep-value: 0.260495% CI: [-1.1, 4]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 30 mg for Week 6 SCCAI scorep-value: 0.280995% CI: [-1.1, 3.8]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 100 mg for Week 6 SCCAI scorep-value: 0.603895% CI: [-1.8, 3.1]Repeated measures mixed model
Comparison: Asacol versus GSK1399686 300 mg for Week 6 SCCAI scorep-value: 0.251195% CI: [-1.1, 3.9]Repeated measures mixed model
Secondary
Median Time to Clinical Response and Clinical Remission
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Time to Clinical Response and Clinical Remission | Clinical response | 18.0 Days |
| Placebo | Median Time to Clinical Response and Clinical Remission | Clinical remission | 41.0 Days |
| GSK1399686 10 mg | Median Time to Clinical Response and Clinical Remission | Clinical response | 16.5 Days |
| GSK1399686 10 mg | Median Time to Clinical Response and Clinical Remission | Clinical remission | 16.5 Days |
| GSK1399686 30 mg | Median Time to Clinical Response and Clinical Remission | Clinical response | 26.0 Days |
| GSK1399686 30 mg | Median Time to Clinical Response and Clinical Remission | Clinical remission | 35.0 Days |
| GSK1399686 100 mg | Median Time to Clinical Response and Clinical Remission | Clinical response | 27.5 Days |
| GSK1399686 100 mg | Median Time to Clinical Response and Clinical Remission | Clinical remission | 20.5 Days |
| GSK1399686 300 mg | Median Time to Clinical Response and Clinical Remission | Clinical response | 13.0 Days |
| GSK1399686 300 mg | Median Time to Clinical Response and Clinical Remission | Clinical remission | 31.0 Days |
| Asacol | Median Time to Clinical Response and Clinical Remission | Clinical response | 22.0 Days |
| Asacol | Median Time to Clinical Response and Clinical Remission | Clinical remission | 23.0 Days |
Secondary
Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 4 Participants |
| Placebo | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 3 Participants |
| Placebo | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 6 Participants |
| Placebo | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 7 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 2 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 2 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 2 Participants |
| GSK1399686 10 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 2 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 1 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 3 Participants |
| GSK1399686 30 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 3 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 2 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 4 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 3 Participants |
| GSK1399686 100 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 3 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 2 Participants |
| GSK1399686 300 mg | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 3 Participants |
| Asacol | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 4 | 4 Participants |
| Asacol | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 4 | 6 Participants |
| Asacol | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Response, Week 6 | 5 Participants |
| Asacol | Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6 | Clinical Remission, Week 6 | 7 Participants |
Secondary
Plasma Clearance Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data
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.
Time frame: 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.
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK1399686 10 mg | 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 | 0.1294 ng/mL | Geometric Coefficient of Variation 178.3 |
| GSK1399686 30 mg | 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 | 0.4930 ng/mL | Geometric Coefficient of Variation 218 |
| GSK1399686 100 mg | 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 | 1.4066 ng/mL | Geometric Coefficient of Variation 85.7 |
Secondary
Volume of Distribution Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data
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.
Time frame: 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.