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GSK2126458 · 2 trials · 2 indications
Pharmacodynamic will be measured by inhibition of pAKT/AKT in platelet-rich plasma and BAL cells, as well as inhibition of glucose uptake as measured by thoracic\[18F\]-FDG-PET/CT
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 PK parameters in blood in order to define the blood and pulmonary PK/PD relationship for GSK2126458 in IPF subjects
GSK2126458 concentration in BALF in order to define the pulmonary PK/PD relationship for GSK2126458 in IPF subjects
| Arm | Type | Description |
|---|---|---|
| Cohort 1-GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 (0.25 mg twice daily \[bid\]) or placebo for approximately 8 days (7 to 10 days dosing) |
| Cohort 1-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing) |
| Cohort 2-GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 1 and which could be escalated or deescalated or repeated from Cohort 1 dosing. |
| Cohort 2-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 3- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 2 and which could be escalated or deescalated or repeated from Cohort 2 dosing. |
| Cohort 3-Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 4- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 3 and which could be escalated or deescalated or repeated from Cohort 3 dosing. |
| Cohort 4- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 5- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 4 and which could be escalated or deescalated or repeated from Cohort 4 dosing. |
| Cohort 5- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| Cohort 6- GSK2126458 | EXPERIMENTAL | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or placebo for approximately 8 days (7 to 10 days dosing). GSK2126458 dose will be decided from Cohort 4 and which could be escalated or deescalated or repeated from Cohort 5 dosing. |
| Cohort 6- Placebo | PLACEBO_COMPARATOR | Subjects will be randomized in 3:1 ratio to receive either GSK2126458 bid or matching placebo for approximately 8 days (7 to 10 days dosing). |
| GSK2126458 | EXPERIMENTAL | GSK2126458 will be dosed continuously (every day) for the duration a 28 day cycle. The 28 day cycles will continue until the subjects withdraw from the study. |
| Name | Type | Description |
|---|---|---|
| GSK2126458 | DRUG | GSK2126458 will be available as film coated tablet of dose strength 0.25 mg and 0.5 mg |
| Placebo | DRUG | Matching placebo will be available |
Inclusion Criteria: * Diagnosis of IPF as determined by a responsible and experienced chest physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Conse...
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GSK2126458 is an investigational small molecule being studied for the treatment of solid tumours and idiopathic pulmonary fibrosis (IPF). It is developed by GSK plc (ticker: GSK) and is currently in Phase 1 clinical development. The drug has been evaluated in clinical trials for these conditions.
GSK2126458 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for solid tumours and idiopathic pulmonary fibrosis.
GSK2126458 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for solid tumours and idiopathic pulmonary fibrosis.
GSK2126458 has been studied in two completed Phase 1 clinical trials. The first, NCT00972686, was a dose-escalation study in patients with solid tumours, enrolling 79 participants in the United States and Netherlands. The second, NCT01725139, was a proof of mechanism study in patients with idiopathic pulmonary fibrosis, enrolling 17 participants in the United Kingdom.
GSK2126458 is also known as omipalisib. It is an investigational small molecule being developed by GSK plc for the treatment of solid tumours and idiopathic pulmonary fibrosis. The drug is currently in Phase 1 clinical development.