Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2269557 500 µg · 1 trial · 1 indication
Whole blood samples of approximately 2 milliliters were collected for measurement of plasma concentrations of GSK2269557 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population which comprised of all randomized participants in the Safety Population and for whom a PK sample was obtained and analyzed.
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Type | Description |
|---|---|---|
| GSK2269557 500 µg receivers | EXPERIMENTAL | Randomized healthy subjects will receive single dose of GSK2269557 500 µg via inhalation route via the ELLIPTA DPI. |
| GSK2269557 750 µg receivers | EXPERIMENTAL | Randomized healthy subjects will receive single dose of GSK2269557 750 µg via inhalation route via the ELLIPTA DPI. |
| Name | Type | Description |
|---|---|---|
| GSK2269557 500 µg | DRUG | GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 500 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI. |
| GSK2269557 750 µg | DRUG | GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 750 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI. |
Inclusion Criteria: * Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG tests. Re-screening will be allowed o...
GSK2269557 500 µg is an investigational inhaled small molecule being studied in chronic obstructive pulmonary disease (COPD), a respiratory condition. It is in Phase 1 clinical development and has not been approved for any indication. The 500 µg designation refers to the dose strength evaluated in clinical testing.
GSK2269557 500 µg targets PIK3CD, also known as phosphoinositide 3-kinase delta. It is a small molecule inhibitor of this target. Inhibiting PIK3CD is the intended mechanism of action for this investigational compound in respiratory disease research.
GSK2269557 500 µg is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program evaluating this compound in chronic obstructive pulmonary disease.
GSK2269557 500 µg is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has completed its single listed trial.
GSK2269557 500 µg has been evaluated in one completed Phase 1 trial, NCT03189589, titled Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects. The trial enrolled 12 healthy volunteers in the United Kingdom and was randomized, double-blind, and controlled.