| Primary | Number of Participants With Abnormal Ophthalmic Examination Findings | Ophthalmic examinations for Pupil motility and confrontation visual field examination, slit lamp evaluation of anterior ocular structures, intraocular pressure measurement and optical coherence tomography (OCT) was performed on left and right eye. Participants with data including abnormalities of potential clinical importance is listed here. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
| | | Title | Denominators | Categories |
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| Eyelids and Lashes | | | | Pupil motility | |
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| Primary | Mean Change From Baseline to Day 28 in Visual Acuity | Best-correct visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The visual function of the study eye was assessed using the ETDRS protocol. ETDRS letters score can be calculated when 20 or more letters are read correctly at 4.0 meters (m); the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus 30. If less than 20 letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m (number of letters recorded on line 1.0), plus the total number of letters read correctly at 1.0 m in the first six lines. The score ranges from 0-100 where a higher score represents better visual functioning. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Pharmacodynamics (PD) analysis set included all participants from the modified Safety population who had at least 1 post-baseline non-missing PD assessment. | Posted | | Mean | Standard Deviation | Letters | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Body Weight | Physical examination included the measuring of body weight and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | kilogram (kg) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Body Temperature | Physical examination included the measuring of body temperature and evaluated at indicated time points. The change from Baseline was calculated by subtracting Baseline value from post-Baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Degree Celsius (°C) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure | The change from baseline for Systolic Blood Pressure (SBP) and Diastolic blood Pressure (DBP) was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Pulse Rate | Pulse rate was measured at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Beats per Minute (beats/min) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings | The 12-lead ECGs was obtained at indicated timepoints during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The change from baseline was calculated by subtracting baseline value from post-baseline value. | The intensive pharmacokinetics (PK) analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase | Summary of changes from baseline in laboratory parameters were assessed. The analysis included liver function tests for ALT, AP, AST, Creatine kinase and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Microkatal per Litre (ukat/L) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen | Summary of changes from baseline in clinical chemistry parameters. The parameters included were calcium, glucose, potassium, sodium and urea nitrogen and evaluated at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per Liter (mmol/L) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin | Summary of changes from baseline in clinical chemistry parameters. The parameters analyzed were creatinine, total bilirubin and direct bilirubin and evaluated at indicated timepoints. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Micromoles per Liter (umol/L) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Protein | Summary of changes from baseline in clinical chemistry parameter, Protein. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Grams per Liter (g/L) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Cardiac Troponin | Summary of changes from baseline in clinical chemistry parameters for Cardiac troponin. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelets | Summary of changes from baseline in hematology. The parameters analyzed were Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils and Platelets at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Giga (10^9) cells per liter | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Summary of changes from baseline in hematology. The parameters analyzed were MCHC and Hb at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | g/L | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin | Summary of changes from baseline in mean corpuscular hemoglobin at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Picograms per cell (pg/cell) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Mean Corpuscular Volume (MCV) | Summary of changes from baseline in hematology MCV assessment. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Erythrocytes | Summary of changes from baseline in erythrocytes at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | 10^12 cells per Liter | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Hematocrit | Summary of changes from baseline in hematocrit parameter at indicated time points. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Ocular and Non-ocular AEs and SAEs | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular AEs and SAEs. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Count of Participants | | Participants | | Until follow-up (Up to Day 56) | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Primary | Mean Change From Baseline to Day 28 in Center Subfield Retinal Thickness as Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT) | The SD-OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of GSK2798745. The mean change from baseline in macular thickness was measured by SD-OCT in the study eye after 28 days of dosing. Measurements was obtained by an appropriately trained photographer/technician using SD-OCT equipment that has been approved by a central reader. The change from baseline was calculated by subtracting baseline value from post-baseline value. | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Posted | | Mean | Standard Deviation | Micrometer (um) | | Baseline and Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Plasma Concentrations of GSK2798745 | Blood samples were collected at indicated time points for plasma concentrations of GSK2798745. | The pharmacokinetic population included all participants from the modified safety population who received at least one dose of study treatment for whom PK sample was obtained and analyzed. Only those participants with evaluable PK data at the specified time points were used for analysis. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | | Day 7 (Pre-dose, 0.5 hour [h], 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h) | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Plasma Concentrations of Major Metabolite M1 | Blood samples were collected at indicated time points for PK analysis of major metabolite of GSK2798745. | The pharmacokinetic population included all participants from the modified safety population who received at least one dose of study treatment for whom PK sample was obtained and analyzed. Only those participants with evaluable PK data at the specified time points were used for analysis. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | | Day 7 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h) and Day 28 (Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h) | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Absorption Rate of GSK2798745 | Blood samples were collected at indicated time points for PK analysis of GSK2798745 absorption rate. | The intensive PK analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Clearance of GSK2798745 | Blood samples were collected at indicated time points for PK parameters including clearance of GSK2798745. | The intensive PK analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | At Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Volume of Distribution of GSK2798745 | Blood samples were collected at indicated time points for PK parameters including volume of distribution of GSK2798745. | The intensive PK analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | At Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of GSK2798745 | Blood samples were collected at indicated time points for PK parameters including Cmax of GSK2798745. | The intensive PK analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | At Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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| Secondary | Area Under Concentration-Time Curve (AUC) Over Dosing Interval of GSK2798745 | Blood samples were collected at indicated time points for PK parameters including AUC of GSK2798745. | The intensive PK analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | Posted | | | | | | At Day 28 | | | | ID | Title | Description |
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| OG000 | GSK2798745 | Eligible participants received single dose of GSK2798745 for 28 days. Participants were instructed to have GSK2798745 about the same time each day. |
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