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 small molecule being developed for chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for use. The drug is intended to be administered at a dose of 500 µg.
GSK2269557 500 µg is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug for chronic obstructive pulmonary disease.
GSK2269557 500 µg is in Phase 1 clinical development. It is an investigational drug for chronic obstructive pulmonary disease and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
GSK2269557 500 µg has been studied in one completed Phase 1 clinical trial, identified as NCT03189589. This trial was titled "Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects" and enrolled 12 participants in the United Kingdom. The trial was randomized, double-blind, and controlled.
GSK2269557 500 µg is a specific dose formulation of the investigational drug GSK2269557. The 500 µg designation refers to the dose strength being studied. The drug is being developed by GSK plc for chronic obstructive pulmonary disease and is currently in Phase 1 clinical trials.