A Double-blind (Sponsor Unblinded) Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Repeat Dosing of GSK2646264 in Cutaneous Lupus Erythematosus Patients

Change From Baseline in Urine Potential of Hydrogen (pH)

时间窗: Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)

Urine samples were collected to monitor the pH. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower number indicates the more acidic urine. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Number of Participants With Emergent Hematology Results by PCI Criteria

时间窗: Day 14, Day 28 and follow-up (up to Day 56)

PCI ranges were hematocrit \[Hct\] (high: \>0.54 proportion of red blood cell \[RBC\] in blood), hemoglobin \[Hb\] (high: \>180 grams per liter), RBC (low: \<4.2x10\^12 cells per liter and high: \>5.9x10\^12 cells per liter), lymphocytes \[Lympho\] (low: \<0.8x10\^9 cells per liter), monocytes \[Mono\] (low: \<0.14x10\^9 cells per liter and high: \>1.3x10\^9 cells per liter), neutrophils \[Neutro\] (low: \<1.5x10\^9 cells per liter), platelet count \[PC\] (low: \<100x10\^9 cells per liter and high: \>550x10\^9 cells per liter), eosinophils \[Eos\] (high: \>0.55x10\^9 cells per liter), basophils \[Baso\] (high: \>0.22x10\^9 cells per liter), white blood cell \[WBC\] (low: \<3x10\^9 cells per liter and high: \>20x10\^9 cells per liter). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Number of Participants With Emergent Chemistry Results by Potential Clinical Importance (PCI) Criteria

时间窗: Day 14, Day 28 and follow-up (up to Day 56)

Blood samples were collected to analyze the clinical chemistry parameters; albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), calcium, glucose, potassium (Pot) and sodium. PCI ranges were albumin (low: \<30 grams per liter), calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L), sodium (low: \<130 mmol/L and high: \>150 mmol/L), ALT (high: \>=2 times upper limit of normal \[ULN\] units per liter {U/L}), AST (high: \>=2 times ULN U/L), ALP (high: \>=2 times ULN U/L) and TB (high: \>=1.5 times ULN micromoles per liter). Safety Population comprised of all participants who received at least one dose of study treatment. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Number of Participants With Emergent Vital Sign Results by PCI Criteria

时间窗: Day 14 and Day 28

Vital signs such as diastolic blood pressure (DBP), heart rate (HR) and systolic blood pressure (SBP) were measured in semi-supine position after 5 minutes rest for the participants. PCI ranges were SBP (lower: \<85 millimeters of mercury \[mmHg\] and upper: \>160 mmHg), DBP: (lower: \<45 mmHg and upper: \>100 mmHg) and HR (lower: \<40 beats per minute \[bpm\] and upper: \>110 bpm). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Change From Baseline in Urine Specific Gravity

时间窗: Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)

Urine samples were collected to monitor the specific gravity. Specific gravity is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Change From Baseline in Electrocardiogram (ECG); HR

时间窗: Baseline (Day 1), Day 14 and follow-up (up to Day 56)

Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Change From Baseline in ECG; PR Interval, QRS Duration, QT Interval and QTcF

时间窗: Baseline (Day 1), Day 14 and follow-up (up to Day 56)

Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Up to Day 56

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