Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02612051 | First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Patients | PHASE1 | COMPLETED | 40 | — | — | Dec 4, 2015 | Jun 2, 2016 | May 1, 2017 | 1 | United Kingdom |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
SpO2 levels are estimates of the amount of oxygen in the blood. SpO2 will be measured by pulse oximetry.
12-lead ECG and cardiac telemetry will be performed.
Forced expiratory volume in 1 second (FEV1) is the volume of air that can forcibly be blown out in one second, after full inspiration. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration. Lung function test will be performed to obtain FEV1 and FVC .
Diffusing capacity (DLCO) is the carbon monoxide uptake from a single inspiration in a standard time (usually 10 seconds). Lung function test will be performed to obtain DLCO.
Subjects will be required to complete a taste questionnaire following dosing.
Hematology laboratory tests will include platelet count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Clinical chemistry laboratory tests will include urea, creatinine, glucose non-fasted, creatinine phosphokinase, potassium, sodium, calcium, aspartate aminotransferase alanine transaminase,total and direct bilirubin, total protein, alkaline phosphatise and albumin.
Urinalysis laboratory tests will include specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal).
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
SpO2 levels are estimates of the amount of oxygen in the blood. SpO2 will be measured by pulse oximetry.
12-lead ECG and cardiac telemetry will be performed.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FVC is the volume of air that can forcibly be blown out after full inspiration. Lung function test will be performed to obtain FEV1 and FVC .
DLCO is the carbon monoxide uptake from a single inspiration in a standard time (usually 10 seconds). Lung function test will be performed to obtain DLCO.
Subjects will be required to complete a taste questionnaire following dosing.
Positron Emission Tomography (PET) scan and a sample of blood will be taken simultaneously for measurement of \[18F\]-FBA-A20FMDV2 concentration. The blood volume in tissue will be determined by dividing the tissue tracer concentration by the blood value. Changes in the uptake of \[18F\]-FBA-A20FMDV2 in the lung will be calculated.
Hematology laboratory tests will include platelet count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Clinical chemistry laboratory tests will include urea, creatinine, glucose fasted, creatinine phosphokinase, potassium, sodium, calcium, aspartate aminotransferase alanine transaminase, total and direct bilirubin, total protein, alkaline phosphatise and albumin.
Urinalysis laboratory tests will include specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal)
PET scan and a sample of blood will be taken simultaneously for measurement of \[18F\]-FBA-A20FMDV2 concentration. The blood volume in tissue will be determined by dividing the tissue tracer concentration by the blood value. Changes in the uptake of \[18F\]-FBA-A20FMDV2 in the lung will be calculated.
| Arm | Type | Description |
|---|---|---|
| Part A, Cohort 1: GSK3008348 1-3000 mcg/Placebo | EXPERIMENTAL | Healthy subjects will receive single 3 ascending doses of GSK3008348 (ranging from 1 to 3000 microgram \[mcg\]) and matching placebo by nebulisation in one of the four treatment period according to randomization. There will be washout period of at least 6 days between the doses. Actual doses may involve either an increase or a decrease in the planned dose as well as a repeat of the previous. |
| Part A, Cohort 2: GSK3008348 1-3000 mcg/Placebo | EXPERIMENTAL | Healthy subjects will receive single 3 ascending doses of GSK3008348 (ranging from 1 to 3000 microgram \[mcg\]) and matching placebo by nebulisation in one of the four treatment period according to randomization. There will be washout period of at least 6 days between the doses. Actual doses may involve either an increase or a decrease in the planned dose as well as a repeat of the previous. |
| Part A, Cohort 3: GSK3008348 1-3000 mcg/Placebo | EXPERIMENTAL | Healthy subjects will receive single 3 ascending doses of GSK3008348 (ranging from 1 to 3000 microgram \[mcg\]) and matching placebo by nebulisation in one of the four treatment period according to randomization. There will be washout period of at least 6 days between the doses. Actual doses may involve either an increase or a decrease in the planned dose as well as a repeat of the previous. |
| Part B, Cohort 4: GSK3008348/Placebo, IPF, Period 2 PET Scan | EXPERIMENTAL | IPF subject will receive single dose of GSK3008348 (safe and tolerated dose as per cohort 1 to 3) or Placebo in two treatment periods according to randomization. There will be washout period of 6 to 28 days between the doses. Subjects will receive up to three microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2. |
| Part B, Cohort 5: GSK3008348/Placebo, IPF, Period 2 PET Scan | EXPERIMENTAL | IPF subject will receive single dose of GSK3008348 (safe and tolerated dose as per cohort 1 to 3) or Placebo in two treatment periods according to randomization. There will be washout period of 6 to 28 days between the doses. Subjects will receive up to three microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2. |
| Part B, Cohort 6: GSK3008348/Placebo, IPF, Period 2 PET Scan | EXPERIMENTAL | IPF subject will receive single dose of GSK3008348 (safe and tolerated dose as per cohort 1 to 3) or Placebo in two treatment periods according to randomization. There will be washout period of 6 to 28 days between the doses. Subjects will receive up to three microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2. |
| Part B, Cohort 7: GSK3008348/Placebo, IPF, Period 2 PET Scan | EXPERIMENTAL | IPF subject will receive single dose of GSK3008348 (safe and tolerated dose as per cohort 1 to 3) or Placebo in two treatment periods according to randomization. There will be washout period of 6 to 28 days between the doses. Subjects will receive up to three microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2. |
| Part C, Cohort 8: GSK3008348, IPF, PET Scan | EXPERIMENTAL | IPF subject will receive single dose of GSK3008348 (safe and tolerated dose as per Part B) in two treatment periods. There will be washout period of 6 to 14 days between the doses. Subjects will receive up to three microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in both periods. |
| Name | Type | Description |
|---|---|---|
| GSK3008348 Nebuliser solution | DRUG | Nebuliser solution formulated at 5000 mcg/mL with 5% mannitol, citric acid, sodium citrate and water for injection, pH adjusted using Hydrochloric acid or Sodium hydroxide to the target pH 5.4 +/- 0.4. 4 ml of diluted dose of appropriate concentration will be administered by nebulisation. |
| Placebo Nebuliser solution | DRUG | 5% mannitol nebuliser solution. 4 ml of solution will be administered by nebulisation |
| GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion | RADIATION | Formulated in 0.9% saline. The maximum amount of radioactivity injected during each PET scan will be 150 Megabecquerel (MBq) and maximum mass of \[18F\]-FBA-A20FMDV2 administered across all three administrations will be 100 mcg. Intravenous bolus infusion of 20 ml will be administered over about 30 seconds. |
Inclusion Criteria: Part A: \- Male and female subjects \>= 18 years at the time of signing the consent form. Parts B and C : \- Male subjects \>= 45 years and female subjects \>= 55 years at the time of signing the consent form. Part A: * Healthy as determined by the investigator or medically...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP02, AP01 |
| MannKind Corporation | MNKD | 1 | PHASE1 | MNKD-201 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |
| AgomAb Therapeutics NV ADR | AGMB | 1 | PHASE1 | AGMB-447 |