| Primary | Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose | The change in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data, was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348. The per-Protocol population consisted of all participants in the Intent-to-Treat population who comply with the protocol and that had at least one evaluable PET measurement post-dose. | Per-Protocol Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per cubic centimeter(mL/cm^3) | | Baseline (pre-dose) and 30 minutes post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
| | | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG0001.664± 19.67
- OG0011.503± 37.32
|
| | 30 minutes post-dose PET scan 1 | | |
| |
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. 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, other situations judged by physician. Intent-to-Treat population consisted of all randomized participants who received at least one dose of study treatment. | Intent-to-Treat Population. | Posted | | Count of Participants | | Participants | | Up to 62 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin | Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Picrograms | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin | Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Picrograms | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume | Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume | Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count | Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Trillion cells per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
|
| Primary | Period 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count | Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Trillion cells per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Chemistry Parameters: Albumin and Total Protein | Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Chemistry Parameters: Albumin and Total Protein | Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Number of Participants With Abnormal Urinalysis Results by Dipstick | Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented. | Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Baseline (Day -1) and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | |
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| Primary | Period 2: Number of Participants With Abnormal Urinalysis Results by Dipstick | Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented. | Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Baseline (Day -1), 24 hours post-GSK3008348 dose and Day 15 (follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | |
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| Primary | Period 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Vital Signs: DBP and SBP | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Millimeter of mercury | | Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Vital Signs: Heart Rate | Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Vital Signs: Heart Rate | Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Vital Sign: Respiration Rate | Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Vital Sign: Respiration Rate | Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Vital Sign: Temperature | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Celsius | | Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Change From Baseline in Vital Sign: Temperature | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Celcius | | Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Number of Participants With Abnormal Findings for 12-lead Electrocardiograms (ECG) Parameters | Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant 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. | Intent-to-Treat Population. | Posted | | Count of Participants | | Participants | | Pre-dose (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 2: Number of Participants With Abnormal Findings for 12-lead ECG Parameters | Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as CS and NCS. Clinically significant 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. | Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Pre-dose (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge), Day 2 (pre-PET scan) and Day 15 (follow-up) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Primary | Period 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) | FEV1 and FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 and FVC was measured using standard spirometry equipment. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Liters | | Baseline (Day -1), 1 hour and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Time (AUC[0-t]) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic population consisted of all participants in the Intent-To-Treat population receiving active dose for whom a pharmacokinetic sample was analyzed. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*picograms per milliliter | | Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
|---|
| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: AUC(0-t) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*picogram per milliliter | | Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the indicated data points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*picograms per milliliter | | Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: AUC(0-infinity) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity). | Posted | | | | | | Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 1: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picograms per milliliter | | Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: Cmax After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picograms per milliliter | | Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 1: Time of Occurrence of Cmax (Tmax) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Median | Full Range | Hours | | Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: Tmax After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Median | Full Range | Hours | | Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: t1/2 After Single Dose Administration of GSK3008348 | Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2. | Posted | | | | | | Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose | | | | ID | Title | Description |
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| OG000 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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| Secondary | Period 2: VT of [18F]-FBAA20FMDV2 in the Whole Lung (Not Corrected for Air Volume) Approximately 24 Hours Post-dose Compared to Pre-dose | The changes in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348 | Per-Protocol Population. Only those participants with PET data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/cm^3 | | Baseline (pre-dose) and 24 hours post-dose PET scan 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of placebo (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of a [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV2 administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. | | OG001 | GSK3008348 1000 mcg | Participants received a single dose of GSK3008348 1000 mcg (solution), inhaled via nebulization on Day 1 in dosing periods 1 and 2. In dosing period 2 only, they received up to 150 MBq of [18F]-FBA-A20FMDV2, via IV infusion, prior to PET imaging at Baseline, 30 minutes and approximately 24 hours post-GSK3008348 dose. Total [18F]-FBA-A20FMDV administration was <=100 mcg per participant. A wash out period of at least 7 and no more than 28 days was maintained between doses in Periods 1 and 2. |
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