Cholestasis
Conditions
Keywords
linerixibat, PBC, itch, GSK2330672, GLIMMER, primary biliary cholangitis, pruritus
Brief summary
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram \[mg\], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.
Interventions
DRUGPlacebo
GSK2330672 matching placebo will be supplied as white film-coated tablets.
DRUGGSK2330672
GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent. * Participants who have proven PBC, as demonstrated by having at least 2 of the following: History of sustained increased ALP levels \>ULN first recognized at least 6 months prior to the Screening Visit (Sustained ALP elevations at the time of Screening is not required, recognizing that the ALP may have decreased after institution of ursodeoxycholic acid (UDCA) therapy as described in inclusion number 4). Documented positive anti-mitochondrial antibody (AMA) titer (\>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and/or nuclear rim positive). Liver biopsy (at any time in the past) consistent with PBC. * Participants must rate their itch severity as being \>=4 on a 0 to 10 point scale for the majority of time (at least half the days, as recalled by the participant) during the 8 weeks prior to the Screening Visit. Periods of low itch or no itch are acceptable as long as the worst daily itch score is \>=4 on the majority of days. * Participants who are currently taking UDCA should be on stable doses of UDCA for \>8 weeks at time of screening. Participants not taking UDCA due to intolerance may be enrolled 8 weeks after their last dose of UDCA. No changes or discontinuation is permitted until completion of the Main Study Period. * Male and/or female: Female participants- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and until at least 4 weeks after the last dose of study treatment. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
* Screening total bilirubin \>2x ULN. Total bilirubin \>2x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent (%). * Screening ALT or AST \>6x ULN. * Screening eGFR \<45 milliliter (mL)/minute/1.73 square meter (m\^2) based on the CKD-EPI. * History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites). * Presence of actively replicating viral hepatitis due to hepatitis B or C virus (HBV, HCV) infection, and/or confirmed hepatocellular carcinoma or biliary cancer. Other hepatic conditions ( e.g., primary sclerosing cholangitis \[PSC\], alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis \[NASH\] ) are permitted if PBC is the dominant liver injury in the investigator's opinion. * Current diarrhea. * Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants with history of cholecystectomy \>=3 months before screening may be eligible for enrolment. * Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect the participant's ability to comply with the protocol specified procedures. * Initiation or increase in dose of colchicine, methotrexate, azathioprine, or systemic corticosteroids in the 2 months prior to screening. If a change in dose in any of these medications is anticipated during the course of the study, the participant should be excluded. * Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3 months prior to screening. Participants may join the study on stable doses of these medications, but no change or discontinuation is permitted until completion of the Main Study Period. * Initiation or increase in dose of any of the following in the 8 weeks prior to screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants may join the study on stable or decreased doses of these medications, but no change in dose is permitted until completion of the Main Study Period. * Bile acid binding resin use: a participant must discontinue use of cholestyramine, colesevelam, colestipol or colestimide prior to the start of the Initial Study Period (no later than Day-2). Note: these drugs may be administered after completion of the Main Study Period, if clinically indicated. * Obeticholic acid use: a participant must discontinue use of obeticholic acid at least 8 weeks prior to the start of the Initial Study Period and may not restart until after the end of the study. * Administration of any other Inhibitor of the Human Ileal Bile Acid Transporter (IBAT) in the 3 months prior to screening. * Current enrolment or participation within the 8 weeks before start of the Initial Study Period, in any other clinical study involving an investigational study treatment. * QT interval corrected for heart rate QTc \>480 millisecond (msec). * History of sensitivity to the study treatment or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation in the study. * History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | Baseline and Week 16 | Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | Baseline and at Week 16 | Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (\>=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (\>)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | At Week 16 | Number of participants with ALP \< 1.67 times ULN and total bilirubin \<= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population. |
| Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
| Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Up to 12 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE. |
| Number of Participants With Non-SAEs and SAEs -Final Study Period | Up to 4 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE. |
| Number of Participants With Non-SAEs and SAEs - Follow-up Period | Up to 4 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE. |
| Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | At Weeks 8, 12, 16 and 20 | Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range \[w/in\] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], high to high), or whose value became within range, were recorded in the To w/in Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100 percent (%). Only To Low and/or To High categories with potential clinical importance data have been presented. |
| Number of Participants With Hematology Data of Potential Clinical Importance | At Weeks 8, 12, 16 and 20 | Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the To w/in Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. Only To Low and/or To High categories with potential clinical importance data have been presented. |
| Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | At Weeks 8, 12, 16 and 20 | A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Baseline and at Week 16 | PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Change From Baseline in Pulse Rate | Baseline and Week 20 | Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Baseline and Week 20 | GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score. |
| Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | At Week 16 | Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of \<4 at Week 16 is presented. |
| Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | Baseline and At Week 16 | Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented. |
| Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | Baseline and At Week 16 | Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented. |
| Percentage of Responder Days With Worst Daily Itch Score of <4 | Up to Week 16 | Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of \<4 is presented. |
| Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | Baseline and at Week 16 | Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.. |
| Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | Baseline and at Week 16 | Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented. |
| Change From Baseline in the Mean Daily Sleep Score at Week 16 | Baseline and at Week 16 | Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Change From Baseline in the Mean Daily Fatigue Score at Week 16 | Baseline and at Week 16 | Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
| Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Baseline and at Week 16 | The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | Baseline and at Week 16 | Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | Baseline and at Week 16 | Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Plasma Concentration of GSK2330672 After Sparse Sampling | At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose) | Blood samples were collected for measurement of plasma GSK2330672 concentration. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and Week 20 | SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
Countries
Australia, Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted across 66 centers in 10 countries. The 40 milligrams (mg) twice daily dose group was added and recruitment into the 20 mg twice daily dose group was discontinued following the pre-specified interim analysis.
Pre-assignment details
A total of 147 adult participants were randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 16 weeks including the Main Study Period and Final Study period. Participants were then followed up for 4 weeks. | 36 |
| GSK2330672 20 mg QD Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period followed by matching placebo for 4 weeks in the Final Study period. Participants were then followed up for 4 weeks. All doses were administered via oral route. | 16 |
| GSK2330672 90 mg QD Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks. All doses were administered via oral route. | 23 |
| GSK2330672 180 mg QD Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route. | 27 |
| GSK2330672 40 mg BID Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final study period. Participants were then followed up for 4 weeks. All doses were administered via oral route. | 23 |
| GSK2330672 90 mg BID Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period followed by matching placebo for 4 weeks in the Final Study Period. Participants were then followed up for 4 weeks All doses were administered via oral route. | 22 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Follow-up (Up to 4 Weeks) | Adverse Event | 0 | 0 | 1 | 2 | 0 | 1 |
| Follow-up (Up to 4 Weeks) | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 |
| Follow-up (Up to 4 Weeks) | Withdrawal by Subject | 0 | 0 | 0 | 2 | 0 | 0 |
| Main Study Period (Up to 12 Weeks) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Main Study Period (Up to 12 Weeks) | Discontinued study treatment and entered follow-up | 0 | 0 | 4 | 8 | 0 | 5 |
| Main Study Period (Up to 12 Weeks) | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | GSK2330672 20 mg QD | GSK2330672 90 mg QD | GSK2330672 180 mg QD | GSK2330672 40 mg BID | GSK2330672 90 mg BID | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.4 Years STANDARD_DEVIATION 11.06 | 58.5 Years STANDARD_DEVIATION 7.35 | 52.5 Years STANDARD_DEVIATION 12.32 | 58.9 Years STANDARD_DEVIATION 11.1 | 55.6 Years STANDARD_DEVIATION 11.23 | 56.2 Years STANDARD_DEVIATION 11.32 | 55.8 Years STANDARD_DEVIATION 11.04 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 8 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 7 Participants | 38 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 26 Participants | 10 Participants | 17 Participants | 19 Participants | 16 Participants | 15 Participants | 103 Participants |
| Sex: Female, Male Female | 34 Participants | 16 Participants | 21 Participants | 25 Participants | 22 Participants | 20 Participants | 138 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 16 | 0 / 23 | 0 / 27 | 0 / 23 | 0 / 22 | 0 / 35 | 0 / 16 | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 17 | 0 / 35 | 0 / 16 | 0 / 23 | 0 / 27 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 17 / 36 | 11 / 16 | 19 / 23 | 24 / 27 | 16 / 23 | 18 / 22 | 2 / 35 | 6 / 16 | 8 / 19 | 2 / 19 | 2 / 21 | 2 / 17 | 0 / 35 | 0 / 16 | 0 / 23 | 0 / 27 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 36 | 0 / 16 | 1 / 23 | 0 / 27 | 0 / 23 | 0 / 22 | 0 / 35 | 0 / 16 | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 17 | 0 / 35 | 1 / 16 | 0 / 23 | 1 / 27 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score
Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline.
Time frame: Baseline and Week 16
Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -1.73 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -2.19 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -2.60 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -2.60 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -2.86 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | -2.25 Scores on a scale |
95% CI: [-1.75, 0.82]
95% CI: [-2.07, 0.31]
95% CI: [-2.03, 0.28]
95% CI: [-2.29, 0.03]
95% CI: [-1.71, 0.65]
Secondary
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment
GSRS is a validated scale used to assess gastrointestinal symptoms experienced by participants over the preceding 5 to 7 days. GSRS was measured for all 5 domains: Average Diarrhea Syndrome Score, Average Indigestion Syndrome Score, Average Constipation Syndrome Score, Average Abdominal Pain Syndrome Score, Average Reflux Syndrome Score. All individual domains are scored on a 7-point Likert scale ranging from 1(not at all) to 7(extremely). Higher score indicate more severe symptoms. The Average Total GSRS score was mean of these 5 domains and ranges from 1 to 7. Higher score indicates worst possible degree of symptoms. The responses summarized at each visit are those given during the week prior to the visit, with exception of Day 1. Baseline is the most recent assessment completed by participant prior to randomization. Change from Baseline was calculated as post-Baseline value minus the Baseline value. Data has been presented for each domain along with the average Total GSRS score.
Time frame: Baseline and Week 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | 0.22 Scores on a scale | Standard Deviation 1.343 |
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | -0.01 Scores on a scale | Standard Deviation 1.138 |
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | -0.03 Scores on a scale | Standard Deviation 1.045 |
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | -0.05 Scores on a scale | Standard Deviation 1.074 |
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.09 Scores on a scale | Standard Deviation 1.208 |
| Placebo | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | 0.01 Scores on a scale | Standard Deviation 0.83 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | 0.09 Scores on a scale | Standard Deviation 0.865 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | 0.06 Scores on a scale | Standard Deviation 0.712 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | 0.02 Scores on a scale | Standard Deviation 0.668 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | 0.15 Scores on a scale | Standard Deviation 1.587 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | -0.15 Scores on a scale | Standard Deviation 0.989 |
| GSK2330672 20 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.13 Scores on a scale | Standard Deviation 0.619 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | 0.07 Scores on a scale | Standard Deviation 0.802 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.20 Scores on a scale | Standard Deviation 1.332 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | -0.02 Scores on a scale | Standard Deviation 1 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | 0.32 Scores on a scale | Standard Deviation 1.37 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | 0.23 Scores on a scale | Standard Deviation 1.18 |
| GSK2330672 90 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | -0.03 Scores on a scale | Standard Deviation 0.811 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | -0.06 Scores on a scale | Standard Deviation 0.629 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | -0.14 Scores on a scale | Standard Deviation 0.82 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | -0.02 Scores on a scale | Standard Deviation 0.934 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | -0.11 Scores on a scale | Standard Deviation 0.433 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.26 Scores on a scale | Standard Deviation 0.664 |
| GSK2330672 180 mg QD | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | -0.13 Scores on a scale | Standard Deviation 0.637 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | -0.23 Scores on a scale | Standard Deviation 1.729 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.16 Scores on a scale | Standard Deviation 0.762 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | -0.31 Scores on a scale | Standard Deviation 1.046 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | -0.32 Scores on a scale | Standard Deviation 1.215 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | -0.08 Scores on a scale | Standard Deviation 0.885 |
| GSK2330672 40 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | -0.23 Scores on a scale | Standard Deviation 0.69 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Abdominal Pain Syndrome Score | -0.25 Scores on a scale | Standard Deviation 0.904 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Constipation Syndrome Score | -0.37 Scores on a scale | Standard Deviation 0.772 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Reflux Syndrome Score | -0.43 Scores on a scale | Standard Deviation 0.847 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Total Score | -0.28 Scores on a scale | Standard Deviation 0.695 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Indigestion Syndrome Score | -0.54 Scores on a scale | Standard Deviation 1.007 |
| GSK2330672 90 mg BID | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Assessment | Average Diarrhea Syndrome Score | 0.22 Scores on a scale | Standard Deviation 1.565 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured in a semi-supine position after 5 minutes of rest. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Week 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate | 1.5 Beats per minute | Standard Deviation 7.19 |
| GSK2330672 20 mg QD | Change From Baseline in Pulse Rate | -2.6 Beats per minute | Standard Deviation 10.35 |
| GSK2330672 90 mg QD | Change From Baseline in Pulse Rate | 1.2 Beats per minute | Standard Deviation 10.91 |
| GSK2330672 180 mg QD | Change From Baseline in Pulse Rate | -0.2 Beats per minute | Standard Deviation 7.93 |
| GSK2330672 40 mg BID | Change From Baseline in Pulse Rate | 3.4 Beats per minute | Standard Deviation 8.92 |
| GSK2330672 90 mg BID | Change From Baseline in Pulse Rate | 0.5 Beats per minute | Standard Deviation 8.03 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Week 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 13.33 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 8.99 |
| GSK2330672 20 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -2.1 Millimeters of mercury (mmHg) | Standard Deviation 11.47 |
| GSK2330672 20 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 7.75 |
| GSK2330672 90 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 12.78 |
| GSK2330672 90 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 9.16 |
| GSK2330672 180 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 10.42 |
| GSK2330672 180 mg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 5.51 |
| GSK2330672 40 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 15.16 |
| GSK2330672 40 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 8.64 |
| GSK2330672 90 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 15.43 |
| GSK2330672 90 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 7.23 |
Secondary
Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16
The 5-D itch scale had been developed as a brief, single page, instrument for the multidimensional quantification of itch that is sensitive to change over time. It has data to support its validity in a population of participants with pruritus and covers five dimensions of itch experienced by participants: duration, degree, direction, disability and distribution. Each domain was scored on a 5-point scale, ranging from 1 (Not present/resolved/never) to 5 (unbearable/getting worse/always), higher scores indicates worst itching. The scores of each of five domains were achieved separately and then summed together to obtain a total 5-D score. A total 5-D scores potentially ranged between 5 (no pruritus) and 25 (most severe pruritus) where higher score indicates worse possible itching. Baseline is assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -0.8 Scores on a scale |
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.7 Scores on a scale |
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -0.7 Scores on a scale |
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.4 Scores on a scale |
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.4 Scores on a scale |
| Placebo | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -3.0 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.9 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.8 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -4.0 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -0.9 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -0.7 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.7 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -3.0 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.7 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.5 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -0.7 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -0.4 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.7 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.7 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.7 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -0.9 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -4.4 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.9 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -1.2 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -0.6 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.7 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.9 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -1.1 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.7 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -3.8 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Disability | -0.7 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Direction | -0.7 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Distribution | -0.6 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | 5-D Itch Total Score | -3.5 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Degree | -0.8 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Five-Dimensional (5-D) Itch Scale at Week 16 | Duration | -0.7 Scores on a scale |
95% CI: [-0.7, 0.5]
95% CI: [-0.2, 0.9]
95% CI: [-1, 0.1]
95% CI: [-0.3, 0.7]
95% CI: [-0.4, 0.6]
95% CI: [-0.8, 0.3]
95% CI: [-0.5, 0.5]
95% CI: [-0.6, 0.5]
95% CI: [-0.7, 0.3]
95% CI: [-0.6, 0.4]
95% CI: [-0.7, 0.7]
95% CI: [-0.7, 0.6]
95% CI: [-0.8, 0.5]
95% CI: [-1, 0.2]
95% CI: [-0.6, 0.6]
95% CI: [-1.1, 0.3]
95% CI: [-0.8, 0.5]
95% CI: [-1, 0.3]
95% CI: [-1, 0.3]
95% CI: [-1, 0.3]
95% CI: [-0.9, 0.3]
95% CI: [-0.9, 0.2]
95% CI: [-1, 0]
95% CI: [-0.9, 0.2]
95% CI: [-0.7, 0.3]
95% CI: [-3.3, 1.3]
95% CI: [-2.2, 2.1]
95% CI: [-3.5, 0.7]
95% CI: [-3, 1.2]
95% CI: [-2.7, 1.6]
Secondary
Change From Baseline in the Mean Daily Fatigue Score at Week 16
Mean Daily Fatigue Score is defined as the average of the daily fatigue scores provided in the 7 days prior to the relevant visit. Participants fatigue level was recorded in an electronic diary each evening using a 0-10 NRS in which 0: no fatigue to 10:worst possible fatigue. Higher score indicates worse possible fatigue. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -0.79 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -1.18 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -1.19 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -1.04 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -1.20 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Mean Daily Fatigue Score at Week 16 | -1.07 Scores on a scale |
95% CI: [-1.49, 0.71]
95% CI: [-1.41, 0.61]
95% CI: [-1.24, 0.72]
95% CI: [-1.39, 0.56]
95% CI: [-1.28, 0.7]
Secondary
Change From Baseline in the Mean Daily Sleep Score at Week 16
Mean Daily Sleep Score is defined as the average of the daily sleep scores provided in the 7 days prior to the relevant visit. Participants sleep quality was recorded in an electronic diary each morning using a 0-10 NRS in which 0: good sleep to 10:worst possible sleep. Higher score indicates worse possible sleep. Baseline is the average of the scores in the 7 days prior to the Week 4 (V3) visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -1.39 Scores on a scale |
| GSK2330672 20 mg QD | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -1.66 Scores on a scale |
| GSK2330672 90 mg QD | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -1.87 Scores on a scale |
| GSK2330672 180 mg QD | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -1.85 Scores on a scale |
| GSK2330672 40 mg BID | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -2.35 Scores on a scale |
| GSK2330672 90 mg BID | Change From Baseline in the Mean Daily Sleep Score at Week 16 | -1.69 Scores on a scale |
95% CI: [-1.46, 0.92]
95% CI: [-1.58, 0.62]
95% CI: [-1.53, 0.61]
95% CI: [-2.03, 0.12]
95% CI: [-1.4, 0.8]
Secondary
Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | 0.0 Grams per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | -0.5 Grams per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | 0.3 Grams per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | 0.8 Grams per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | 0.0 Grams per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | 0.7 Grams per Liter |
95% CI: [-2.7, 1.6]
95% CI: [-1.5, 2.1]
95% CI: [-1.2, 2.7]
95% CI: [-2.1, 2]
95% CI: [-1.5, 2.9]
Secondary
Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale
PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | 0.2 Scores on a scale |
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -2.3 Scores on a scale |
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | -1.8 Scores on a scale |
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | -0.3 Scores on a scale |
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -0.5 Scores on a scale |
| Placebo | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | -0.8 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -1.9 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | -0.3 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | -0.5 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | 0.4 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | -2.4 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -1.4 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | 0.4 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -0.4 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | -0.9 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | -1.1 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | 0.7 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -2.6 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | -0.1 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -2.7 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | 1.7 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | -0.6 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -0.6 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | -0.9 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | 0.3 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -1.4 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -3.4 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | -0.1 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | 0.1 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | -3.1 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Cognitive | -0.1 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Fatigue | -1.8 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Emotional | -0.6 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Social | -1.0 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Itch | -2.7 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Symptoms | 0.2 Scores on a scale |
95% CI: [-2.3, 2.7]
95% CI: [-4.8, 0.1]
95% CI: [-2.8, 2.4]
95% CI: [-1.9, 2.3]
95% CI: [-1.5, 2.5]
95% CI: [-3.1, 0.8]
95% CI: [-1.8, 2]
95% CI: [-2, 1.9]
95% CI: [-1.3, 2.2]
95% CI: [-1.8, 1.3]
95% CI: [-1.9, 1.2]
95% CI: [-2.6, 0.5]
95% CI: [-1.9, 1.3]
95% CI: [-4.5, 3.2]
95% CI: [-2.8, 4.2]
95% CI: [0, 7]
95% CI: [-1.8, 5.1]
95% CI: [-3.6, 3.6]
95% CI: [-2.5, 2.6]
95% CI: [-2.9, 1.7]
95% CI: [-2.1, 2.5]
95% CI: [-1.8, 2.8]
95% CI: [-2.2, 2.5]
95% CI: [-2.1, 0.4]
95% CI: [-0.9, 1.3]
95% CI: [-1.2, 1.1]
95% CI: [-1.9, 0.3]
95% CI: [-1.2, 1.1]
95% CI: [-2.4, 3]
95% CI: [-1.3, 3.7]
Secondary
Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | 0.01 Ratio |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | -0.01 Ratio |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | -0.03 Ratio |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | 0.01 Ratio |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | -0.02 Ratio |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | -0.03 Ratio |
95% CI: [-0.08, 0.04]
95% CI: [-0.09, 0.01]
95% CI: [-0.06, 0.05]
95% CI: [-0.09, 0.02]
95% CI: [-0.1, 0.02]
Secondary
Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | -0.10 Seconds |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | 0.05 Seconds |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | -0.21 Seconds |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | 0.02 Seconds |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | -0.18 Seconds |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Prothrombin Time, Among Those With a High Risk of PBC Progression | -0.17 Seconds |
95% CI: [-0.33, 0.63]
95% CI: [-0.51, 0.3]
95% CI: [-0.34, 0.58]
95% CI: [-0.54, 0.38]
95% CI: [-0.54, 0.41]
Secondary
Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4)
Blood samples were collected for evaluating C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 4.746 Micrograms per Liter | Standard Deviation 11.5644 |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 10.703 Micrograms per Liter | Standard Deviation 24.6045 |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 11.452 Micrograms per Liter | Standard Deviation 16.6371 |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 29.488 Micrograms per Liter | Standard Deviation 38.7584 |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 58.674 Micrograms per Liter | Standard Deviation 59.4833 |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum 7-alpha Hydroxy-4-cholesten-3-one (C4) | 40.629 Micrograms per Liter | Standard Deviation 36.2769 |
Secondary
Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | 13.0 International Units per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | -8.4 International Units per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | 0.3 International Units per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | -2.0 International Units per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | -13.5 International Units per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | 13.2 International Units per Liter |
95% CI: [-58.4, 15.5]
95% CI: [-41.9, 16.4]
95% CI: [-49.9, 20]
95% CI: [-63.3, 10.4]
95% CI: [-36.7, 37.1]
Secondary
Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression
Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (\>=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (\>)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations \>=1.67 times ULN and/or total bilirubin concentrations \>ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | 49.1 International units per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | -57.7 International units per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | -38.2 International units per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | 49.6 International units per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | -29.2 International units per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | 19.1 International units per Liter |
95% CI: [-170.7, 110.7]
95% CI: [-251.7, 38.2]
95% CI: [-198.5, 23.8]
95% CI: [-125.6, 126.5]
95% CI: [-211.5, 54.8]
Secondary
Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | 13.96 International Units per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | -6.04 International Units per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | -10.75 International Units per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | -8.66 International Units per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | -17.72 International Units per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | 8.16 International Units per Liter |
95% CI: [-52.73, 12.74]
95% CI: [-50.8, 1.39]
95% CI: [-53.39, 8.16]
95% CI: [-63.44, 0.09]
95% CI: [-38.33, 26.74]
Secondary
Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | 47.5 International Units per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | -58.5 International Units per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | -18.0 International Units per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | 4.6 International Units per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | -18.4 International Units per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | -6.7 International Units per Liter |
95% CI: [-205.1, -6.8]
95% CI: [-148.5, 17.6]
95% CI: [-136.5, 50.9]
95% CI: [-161.2, 29.5]
95% CI: [-153.6, 45.3]
Secondary
Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration
Blood samples were collected for evaluating total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and at Week 16
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | -4.274 Micromoles per Liter | Standard Deviation 20.0163 |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | -0.469 Micromoles per Liter | Standard Deviation 6.5466 |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | -3.878 Micromoles per Liter | Standard Deviation 40.1857 |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | -1.114 Micromoles per Liter | Standard Deviation 6.9359 |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | -2.133 Micromoles per Liter | Standard Deviation 8.9308 |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Serum Total Bile Acid Concentration | 7.379 Micromoles per Liter | Standard Deviation 38.8282 |
Secondary
Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression
Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline.
Time frame: Baseline and at Week 16
Population: High Risk Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | 1.258 Micromoles per Liter |
| GSK2330672 20 mg QD | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | -4.841 Micromoles per Liter |
| GSK2330672 90 mg QD | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | -1.079 Micromoles per Liter |
| GSK2330672 180 mg QD | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | -0.975 Micromoles per Liter |
| GSK2330672 40 mg BID | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | -0.234 Micromoles per Liter |
| GSK2330672 90 mg BID | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | 6.494 Micromoles per Liter |
95% CI: [-11.929, -0.268]
95% CI: [-6.962, 2.289]
95% CI: [-7.679, 3.215]
95% CI: [-7.413, 4.43]
95% CI: [-0.591, 11.063]
Secondary
Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters
A 12-lead ECG was recorded with the participant in a semi-supine position. 12-lead ECGs were obtained by using an automated ECG machine. Data for abnormal, not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: At Weeks 8, 12, 16 and 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 9 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 8 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 9 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 10 Participants |
| Placebo | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 2 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 3 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 3 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 3 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 2 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 2 Participants |
| GSK2330672 90 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 3 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 7 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 5 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 7 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 8 Participants |
| GSK2330672 180 mg QD | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 8 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 8 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 8 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 7 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 12, n= 35, 16, 20, 23, 22, 21 | 4 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 16, n=35, 16, 21, 21, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 16, n= 35, 16, 21, 21, 22 ,21 | 4 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 8, n=36, 16, 21, 21, 22,19 | 4 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 20, n=35, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, NCS, Week 20, n=35, 16, 22, 22, 22, 20 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Parameters | Abnormal, CS, Week 12, n=35, 16, 20, 23, 22, 21 | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Data of Potential Clinical Importance
Blood samples were collected to measure analyze the following parameters: albumin, calcium, Glomerular filtration rate (GFR) from creatinine, glucose, potassium and sodium. Participants were counted in the worst case category that their value changes to (low, within range \[w/in\] or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], high to high), or whose value became within range, were recorded in the To w/in Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100 percent (%). Only To Low and/or To High categories with potential clinical importance data have been presented.
Time frame: At Weeks 8, 12, 16 and 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To High, Week 8, n=36, 16, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 16, n=35, 16, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Sodium, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | GFR, To Low, Week 12, n=35, 15, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium, To High, Week 20, n=35, 16, 22,22, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Glucose ,To Low, Week 16, n=35, 16, 21, 22, 21,20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Potassium,To Low, Week 8, n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Albumin, To Low, Week 16, n=35, 16, 21, 22, 21, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To Low, Week 12, n=35, 16, 21, 23, 22, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Clinical Chemistry Data of Potential Clinical Importance | Calcium, To High, Week 20, n=35, 16, 22, 22, 22, 21 | 0 Participants |
Secondary
Number of Participants With Hematology Data of Potential Clinical Importance
Blood samples were collected to analyze the following parameters: hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Participants were counted in the worst case category that their value changes to (low, w/in or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., high to high), or whose value became within range, were recorded in the To w/in Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. Only To Low and/or To High categories with potential clinical importance data have been presented.
Time frame: At Weeks 8, 12, 16 and 20
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 2 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 1 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| Placebo | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 1 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 2 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 3 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 2 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 12, n=32, 15, 21, 23, 22, 20 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 8, n=35,15, 21, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To High, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 20, n=34,16, 22, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 20, n=34,16, 22, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 8,n=36,15, 20, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 12, n=33,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 20, n=33,16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To High, Week 8,n=36,15, 20, 21, 22, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes,To High, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 12, n=33,14,19, 23, 22, 20 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes, To Low, Week 8, n=36,15, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 20, n=34,16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 12, n=33, 14, 19, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 16, n=35, 15, 21, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 12, n=33,15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets, To Low, Week 16, n=35, 14, 19, 22, 21, 21 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin, To High, Week 8,n=36,16, 21, 21, 22,19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 20, n=33, 16, 21, 21, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 16, n=34, 15, 21, 22, 20, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets,To High, Week 16, n=35, 14, 19, 22, 21, 21 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes, To Low, Week 12, n=32,15,21,23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 12, n=33, 15, 21, 23, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 20, n=34, 16, 22, 22, 22, 20 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils, To Low, Week 8,n=35,15, 21, 21, 22, 19 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit, To High, Week 8,n=36, 16, 21, 21, 22, 19 | 0 Participants |
Secondary
Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline
Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
Time frame: Baseline and At Week 16
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 14 Participants |
| GSK2330672 20 mg QD | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 6 Participants |
| GSK2330672 90 mg QD | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 12 Participants |
| GSK2330672 180 mg QD | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 9 Participants |
| GSK2330672 40 mg BID | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 13 Participants |
| GSK2330672 90 mg BID | Number of Participants With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 12 Participants |
95% CI: [0.27, 3.04]
95% CI: [0.73, 6.91]
95% CI: [0.35, 3.08]
95% CI: [0.73, 6.42]
95% CI: [0.67, 5.99]
Secondary
Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline
Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the most recent assessment completed by the participant prior to randomization. Number of participants with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
Time frame: Baseline and At Week 16
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 17 Participants |
| GSK2330672 20 mg QD | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 9 Participants |
| GSK2330672 90 mg QD | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 15 Participants |
| GSK2330672 180 mg QD | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 14 Participants |
| GSK2330672 40 mg BID | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 15 Participants |
| GSK2330672 90 mg BID | Number of Participants With Improvement of >= 30 Percent (%) in the Mean Worst Daily Itch Score at Week 16 From Baseline | 14 Participants |
95% CI: [0.41, 4.47]
95% CI: [0.95, 10.65]
95% CI: [0.62, 5.53]
95% CI: [0.74, 6.92]
95% CI: [0.69, 6.51]
Secondary
Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16
Participants were required to score the severity of their itching using a 0-10 NRS where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Number of participants with Mean Worst Daily Itch Score of \<4 at Week 16 is presented.
Time frame: At Week 16
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 21 Participants |
| GSK2330672 20 mg QD | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 13 Participants |
| GSK2330672 90 mg QD | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 14 Participants |
| GSK2330672 180 mg QD | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 18 Participants |
| GSK2330672 40 mg BID | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 18 Participants |
| GSK2330672 90 mg BID | Number of Participants With Mean Worst Daily Itch Score of <4 at Week 16 | 14 Participants |
95% CI: [0.69, 12.02]
95% CI: [0.48, 5.02]
95% CI: [0.84, 10.76]
95% CI: [0.84, 10.76]
95% CI: [0.43, 4.13]
Secondary
Number of Participants With Non-SAEs and SAEs -Final Study Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Time frame: Up to 4 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 2 Participants |
| Placebo | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 6 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 8 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 2 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 2 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-SAEs and SAEs -Final Study Period | Any non-SAE | 2 Participants |
Secondary
Number of Participants With Non-SAEs and SAEs - Follow-up Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Time frame: Up to 4 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
| Placebo | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 1 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 1 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-SAEs and SAEs - Follow-up Period | Any non-SAE | 0 Participants |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Time frame: Up to 12 weeks
Population: Safety Population. It consisted of all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 17 Participants |
| Placebo | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 11 Participants |
| GSK2330672 20 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 19 Participants |
| GSK2330672 90 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 1 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 24 Participants |
| GSK2330672 180 mg QD | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 16 Participants |
| GSK2330672 40 mg BID | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any non-SAE | 18 Participants |
| GSK2330672 90 mg BID | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) -Main Study Period | Any SAE | 0 Participants |
Secondary
Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16
Number of participants with ALP \< 1.67 times ULN and total bilirubin \<= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population.
Time frame: At Week 16
Population: Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 0 Participants |
| GSK2330672 20 mg QD | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 0 Participants |
| GSK2330672 90 mg QD | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 0 Participants |
| GSK2330672 180 mg QD | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 0 Participants |
| GSK2330672 40 mg BID | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | 1 Participants |
Secondary
Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline
Percentage of Responder Days with Worst Daily Itch was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>=2 in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented.
Time frame: Baseline and at Week 16
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 31.56 Percentage of days |
| GSK2330672 20 mg QD | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 37.71 Percentage of days |
| GSK2330672 90 mg QD | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 38.82 Percentage of days |
| GSK2330672 180 mg QD | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 40.69 Percentage of days |
| GSK2330672 40 mg BID | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 51.49 Percentage of days |
| GSK2330672 90 mg BID | Percentage of Responder Days With Improvement of >=2 in the Mean Worst Daily Itch Score at Week 16 From Baseline | 58.60 Percentage of days |
95% CI: [-14.76, 27.06]
95% CI: [-11.32, 25.84]
95% CI: [-8.59, 26.85]
95% CI: [1.36, 38.51]
95% CI: [8.2, 45.87]
Secondary
Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline
Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Baseline is the most recent assessment completed by the participant prior to randomization. Percentage of responder days with improvement of \>= 30% in the Mean Worst Daily Itch Score at Week 16 from Baseline is presented..
Time frame: Baseline and at Week 16
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 38.46 Percentage of days |
| GSK2330672 20 mg QD | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 53.44 Percentage of days |
| GSK2330672 90 mg QD | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 45.43 Percentage of days |
| GSK2330672 180 mg QD | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 50.23 Percentage of days |
| GSK2330672 40 mg BID | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 60.29 Percentage of days |
| GSK2330672 90 mg BID | Percentage of Responder Days With Improvement of >= 30% in the Mean Worst Daily Itch Score at Week 16 From Baseline | 60.03 Percentage of days |
95% CI: [-5.13, 35.1]
95% CI: [-10.9, 24.84]
95% CI: [-5.27, 28.82]
95% CI: [3.96, 39.7]
95% CI: [3.46, 39.69]
Secondary
Percentage of Responder Days With Worst Daily Itch Score of <4
Percentage of Responder Days with Worst Daily Itch score was calculated as: (number of days response from Visit 3+1 to Visit 6-1 divided by number of days from Visit 3+1 to Visit 6-1 with worst daily itch scores available) times 100. Days for which no worst daily itch score was available did not contribute to either the numerator or the denominator. Analysis was performed using ANCOVA model including treatment group. Percentage of responder days with Worst Daily Itch Score of \<4 is presented.
Time frame: Up to Week 16
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percentage of Responder Days With Worst Daily Itch Score of <4 | 40.32 Percentage of days |
| GSK2330672 20 mg QD | Percentage of Responder Days With Worst Daily Itch Score of <4 | 58.53 Percentage of days |
| GSK2330672 90 mg QD | Percentage of Responder Days With Worst Daily Itch Score of <4 | 51.38 Percentage of days |
| GSK2330672 180 mg QD | Percentage of Responder Days With Worst Daily Itch Score of <4 | 58.76 Percentage of days |
| GSK2330672 40 mg BID | Percentage of Responder Days With Worst Daily Itch Score of <4 | 65.80 Percentage of days |
| GSK2330672 90 mg BID | Percentage of Responder Days With Worst Daily Itch Score of <4 | 53.58 Percentage of days |
95% CI: [-2.59, 39]
95% CI: [-7.42, 29.53]
95% CI: [0.82, 36.06]
95% CI: [7, 43.95]
95% CI: [-5.47, 31.99]
Secondary
Plasma Concentration of GSK2330672 After Sparse Sampling
Blood samples were collected for measurement of plasma GSK2330672 concentration.
Time frame: At Week 4 (between 1 and 3 hours post-dose) and At Weeks 8, 12 and 16 (between 1 and 3 hours post-dose, and between 5 and 8 hours post-dose)
Population: Pharmacokinetic (PK) Population consisted of any randomized participant who had at least one PK sample. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5 | 394.00 Picograms per milliliter | Standard Deviation 162.151 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17 | 358.04 Picograms per milliliter | Standard Deviation 665.685 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16 | 300.04 Picograms per milliliter | Standard Deviation 356.268 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13 | 341.39 Picograms per milliliter | Standard Deviation 638.359 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14 | 447.88 Picograms per milliliter | Standard Deviation 1160.518 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5 | 296.33 Picograms per milliliter | Standard Deviation 118.154 |
| Placebo | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4 | 5.00 Picograms per milliliter | — |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13 | 1084.00 Picograms per milliliter | Standard Deviation 1353.089 |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5 | 864.26 Picograms per milliliter | Standard Deviation 1045.467 |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17 | 958.81 Picograms per milliliter | Standard Deviation 1563.265 |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4 | 5.00 Picograms per milliliter | — |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5 | 578.00 Picograms per milliliter | Standard Deviation 651.263 |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16 | 820.87 Picograms per milliliter | Standard Deviation 1143.023 |
| GSK2330672 20 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14 | 1594.16 Picograms per milliliter | Standard Deviation 3133.37 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16 | 2234.28 Picograms per milliliter | Standard Deviation 3420.442 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13 | 2569.00 Picograms per milliliter | Standard Deviation 3727.883 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14 | 2060.51 Picograms per milliliter | Standard Deviation 2888.033 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17 | 2327.58 Picograms per milliliter | Standard Deviation 3737.965 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5 | 3328.50 Picograms per milliliter | Standard Deviation 3185.646 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5 | 1940.50 Picograms per milliliter | Standard Deviation 1128.203 |
| GSK2330672 90 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4 | 32.71 Picograms per milliliter | Standard Deviation 73.325 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14 | 419.47 Picograms per milliliter | Standard Deviation 774.321 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17 | 453.45 Picograms per milliliter | Standard Deviation 967.424 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16 | 339.74 Picograms per milliliter | Standard Deviation 357.914 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13 | 303.83 Picograms per milliliter | Standard Deviation 300.716 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5 | 338.50 Picograms per milliliter | Standard Deviation 236.881 |
| GSK2330672 180 mg QD | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5 | 364.50 Picograms per milliliter | Standard Deviation 217.082 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 5 and 8 hours post-dose, n=3, 3, 4, 2, 5 | 869.40 Picograms per milliliter | Standard Deviation 1148.331 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 16, Between 1 and 3 hours post-dose, n=3, 5, 4, 2, 5 | 703.60 Picograms per milliliter | Standard Deviation 756.01 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 5 and 8 hours post-dose, n=14, 17, 18, 21, 16 | 1990.89 Picograms per milliliter | Standard Deviation 4061.978 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 8, Between 1 and 3 hours post-dose, n=16, 21, 20, 22, 17 | 2908.06 Picograms per milliliter | Standard Deviation 5106.895 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 4, Between 1 and 3 hours post-dose, n=6, 2, 7, 0, 4 | 5.00 Picograms per milliliter | — |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 5 and 8 hours post-dose, n=14, 16, 17, 20, 13 | 2197.16 Picograms per milliliter | Standard Deviation 3604.704 |
| GSK2330672 40 mg BID | Plasma Concentration of GSK2330672 After Sparse Sampling | Week 12, Between 1 and 3 hours post-dose, n=14, 19, 17, 20, 14 | 3531.36 Picograms per milliliter | Standard Deviation 6296.828 |
Post Hoc
Mean Change From Baseline in Monthly Itch Score
Participants were required to score severity of their itching each morning and evening using a 0-10 NRS where 0(no itching) and 10(worst imaginable itching). The worst of these 2 scores was Worst Daily Itch Score. For each week, mean Worst Daily Itch Score was calculated to form Mean Worst Daily Itch Score. The Monthly Itch Score was defined as worst weekly score (e.g., Mean Worst Daily Itch Score) for that month. The monthly itch score ranges from 0 to 10, higher score indicates worst imaginable itching. Baseline is average of scores in the 7 days prior to Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as post-Baseline value minus Baseline value. Mean change from Baseline in monthly itch score over 12 week treatment period is presented. Analysis was performed on change in Monthly Itch Scores over 12 week treatment period using Mixed model repeated measures (MMRM) with Baseline itch, treatment group, visit and a treatment group\*visit interaction as covariates in the model.
Time frame: Baseline and up to Week 12
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change From Baseline in Monthly Itch Score | -0.46 Scores on a scale |
| GSK2330672 20 mg QD | Mean Change From Baseline in Monthly Itch Score | -1.17 Scores on a scale |
| GSK2330672 90 mg QD | Mean Change From Baseline in Monthly Itch Score | -1.08 Scores on a scale |
| GSK2330672 180 mg QD | Mean Change From Baseline in Monthly Itch Score | -1.36 Scores on a scale |
| GSK2330672 40 mg BID | Mean Change From Baseline in Monthly Itch Score | -1.63 Scores on a scale |
| GSK2330672 90 mg BID | Mean Change From Baseline in Monthly Itch Score | -1.41 Scores on a scale |
95% CI: [-1.69, 0.28]
95% CI: [-1.49, 0.26]
95% CI: [-1.76, -0.03]
95% CI: [-2.05, -0.28]
95% CI: [-1.85, -0.06]
Post Hoc
Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration
Blood samples were collected for evaluation of C4 concentration as a marker of bile acid synthesis. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in C4 on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline C4, visit, treatment group, a log-transformed Baseline C4\*visit interaction, and a treatment group\*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.
Time frame: Baseline and up to Week 12
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 1.158 Ratio |
| GSK2330672 20 mg QD | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 1.579 Ratio |
| GSK2330672 90 mg QD | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 2.374 Ratio |
| GSK2330672 180 mg QD | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 2.846 Ratio |
| GSK2330672 40 mg BID | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 3.622 Ratio |
| GSK2330672 90 mg BID | Ratio to Baseline in Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Concentration | 3.127 Ratio |
95% CI: [0.932, 1.995]
95% CI: [1.456, 2.887]
95% CI: [1.758, 3.436]
95% CI: [2.206, 4.435]
95% CI: [1.915, 3.81]
Post Hoc
Ratio to Baseline in Total Serum Bile Acid Concentration
Blood samples were collected for evaluation of total bile acid concentration as a biomarker of PBC. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Ratio to Baseline was defined as the geometric mean of post-Baseline visit value divided by the geometric mean of Baseline value. Values were log-transformed and mean change from Baseline on the log-scale was calculated over the 12 week treatment period. Analysis was performed on change in total serum bile acid concentration on the log-scale over the 12 week treatment period using Mixed model repeated measures (MMRM) with log-transformed Baseline total serum bile acid, visit, treatment group, a log-transformed Baseline total serum bile acid\*visit interaction, and a treatment group\*visit interaction used as covariates in the model. Afterwards, values were back-transformed to the original scale. Ratios of geometric means are presented.
Time frame: Baseline and up to Week 12
Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Ratio to Baseline in Total Serum Bile Acid Concentration | 1.01 Ratio |
| GSK2330672 20 mg QD | Ratio to Baseline in Total Serum Bile Acid Concentration | 0.977 Ratio |
| GSK2330672 90 mg QD | Ratio to Baseline in Total Serum Bile Acid Concentration | 1.182 Ratio |
| GSK2330672 180 mg QD | Ratio to Baseline in Total Serum Bile Acid Concentration | 0.918 Ratio |
| GSK2330672 40 mg BID | Ratio to Baseline in Total Serum Bile Acid Concentration | 0.697 Ratio |
| GSK2330672 90 mg BID | Ratio to Baseline in Total Serum Bile Acid Concentration | 0.833 Ratio |
95% CI: [0.635, 1.471]
95% CI: [0.8, 1.712]
95% CI: [0.627, 1.316]
95% CI: [0.474, 1.005]
95% CI: [0.564, 1.207]