| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; other important medical events; or is associated with liver injury and impaired liver function. | All Subject Population comprised of all participants who received at least one dose of study drug (including GSK1278863, placebo and standard care). | Posted | | Number | | Participants | | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
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| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG002 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | | OG003 | C (Cohort 2) | Participants with DFU were a single dose of 0.1 percent of 25 mg/cm^2 GSK1278863 on wounded skin. | | OG004 | D (Cohort 3) | Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin. | | OG005 | E (Cohort 4) | Participants with DFU were administered a single dose of 1 percent of 100 mg/cm^2 GSK1278863 on wounded skin. |
| | | Title | Denominators | Categories |
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| AEs | | |
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| Primary | Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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; other important medical events; or is associated with liver injury and impaired liver function. | | Posted | | Number | | Participants | | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
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| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. |
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| Primary | Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A) | ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented. | | Posted | | Number | | Participants | | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
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| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | | OG002 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. |
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| Primary | Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B) | ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented. | | Posted | | Number | | Participants | | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
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| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. |
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| Primary | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A) | Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Day 1 (pre-dose and 48 hours) of Periods 1 and 2 | | | | ID | Title | Description |
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| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | | OG002 | A/B (Cohort 1) | |
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| Primary | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B) | Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Days 1 and 7 (pre-dose), Day 14 (24 hours) | | | | ID | Title | Description |
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| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. |
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| Primary | Number of Participants With Abnormal Nurse/Physician Observation (Part A) | A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed.Since data was not collected, no analysis was performed. | | Posted | | | | | | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
|---|
| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | | OG002 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. |
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| Primary | Number of Participants With Abnormal Nurse/Physician Observation (Part B) | A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed. Since data was not collected, no analysis was performed. | | Posted | | | | | | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | | | | ID | Title | Description |
|---|
| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. |
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| Primary | Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A) | Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, absolute neutrophil count (ANC), monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Day 1 (pre-dose) | | | | ID | Title | Description |
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| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. | | OG002 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. |
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| Primary | Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B) | Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, neutrophils, monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Day 1 (pre-dose) | | | | ID | Title | Description |
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| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) | Participants with DFU continued to receive daily application of standard of care wound treatment for 14 days. |
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| Primary | Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part A) | Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Day 1 (pre-dose and 48 hours) in period 1; Day 1 (48 hours) in period 2 | | | | ID | Title | Description |
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| OG000 | Placebo HVT (Cohort 1) | Cohort 1 comprised of healthy participants. Participants were administered a single dose of placebo on intact skin during two dosing periods. There was a wash out period of at least 10 days between the two periods. | | OG001 | Placebo DFU SD (Cohort 2, 3, 4) | Cohorts 2, 3 and 4 consisted of participants with DFU. Participants were administered a single dose of placebo in one (Cohort 3) or two (Cohort 2 and 4) dosing periods. There was a wash out period of at least 10 days between periods. |
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| Primary | Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part B) | Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter. | | Posted | | Number | | Participants | | Days 1 and 7 (pre-dose) and Day 14 (24 hours) | | | | ID | Title | Description |
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| OG000 | Placebo DFU RD (Cohort 5) | Participants with DFU received once daily placebo application directly to the wounded skin for 14 days along with standard of care therapy. | | OG001 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. | | OG002 | Sr (Cohort 5) |
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| Primary | Maximum Observed Concentration (Cmax) of GSK1278863 (Part A) | The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification. | All participants from whom a PK sample had been obtained and analyzed were included in the PK Population | Posted | | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 | D (Cohort 3) |
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| Primary | Cmax of GSK1278863 (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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| Primary | Time of Occurrence of Cmax (Tmax) of GSK1278863 (Part A) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 | D (Cohort 3) | Participants with DFU were administered a single dose of 1 percent of 25 mg/cm^2 GSK1278863 on wounded skin. |
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| Primary | Tmax of GSK1278863 (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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| Primary | Apparent Terminal Elimination Half-life (t1/2) of GSK1278863 (Part A) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 | D (Cohort 3) | |
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| Primary | t1/2 of GSK1278863 (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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| Primary | Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part A) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 | D (Cohort 3) | |
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| Primary | Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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| Primary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] of GSK1278863 (Part A) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | hour*nanograms/milliliter | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 | D (Cohort 3) |
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| Primary | AUC(0-inf) of GSK1278863 (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | hour*nanograms/milliliter | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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| Primary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC(0-t)] of GSK1278863 (Part A) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | hour*nanograms/milliliter | | Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose | | | | ID | Title | Description |
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| OG000 | A/B (Cohort 1) | Healthy participants were enrolled. Participants were administered a single dose of treatment A=0.3 milligram (mg) GSK1278863 on intact skin in Period 1 and a single dose of treatment B=3 mg GSK1278863 on intact skin in Period 2. There was a wash out period of 10 days between the two periods. | | OG001 | C/C (Cohort 2) | Participants with DFU were administered 0.1 percent of 25 milligrams per square centimeter (mg/cm^2) GSK1278863 on intact skin in Period 1 followed by a wash-out period of at least 10 days. Participants were then administered a single dose of 0.1 percent of 25 mg/cm^2 on wounded skin in Period 2. | | OG002 |
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| Primary | AUC(0-t) of GSK1278863 (Part B) | The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification. | | Posted | | Mean | Standard Deviation | hour*nanograms/milliliter | | Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14 | | | | ID | Title | Description |
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| OG000 | R1r (Cohort 5) | Participants with DFU received once daily application of 1 percent of 100 mg/cm^2 GSK1278863 to wounded skin for 14 days along with standard of care treatment. |
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