Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2269557 infusion · 1 trial · 1 indication
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic (PK) Population comprised of participants in the APE Population who received at least one dose of study treatment and for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. NA indicates that data is not available as single participant was analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis. NA indicates that data is not available as single participant was analyzed.
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively.
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Type | Description |
|---|---|---|
| Subjects receiving GSK2269557 in treatment period 1 | EXPERIMENTAL | Eligible subjects will receive IV infusion of \[14C\] radiolabelled GSK2269557 with a single dose of 10 micrograms (µg) administered as single microtracer, concomitantly with an inhaled nonradiolabelled 1000 µg dose of GSK2269557. There will be a washout of at least 14 days after inhaled and IV dosing before subjects receive treatment 2. |
| Subjects receiving GSK2269557 in treatment period 2 | EXPERIMENTAL | Eligible subjects will receive \[14C\]-GSK2269557 with a single dose of 800 µg, administered as an oral solution. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK2269557 IV infusion | DRUG | The \[14C\]-GSK2269557 solution will be available in dosing strength of 10 µg, administered as single dose IV infusion over 15 minutes. It will be prepared by dissolving a hemisuccinate salt (GSK2269557T) in normal saline. |
| GSK2269557 via DPI | DRUG | GSK2269557 DPI will be available with dosing strength of 1000 µg, administered as oral inhalation intended to inhale twice. It will be prepared by blending GSK2269557 hemisuccinate salt (GSK2269557H) with lactose and magnesium stearate. |
| [14C]-GSK2269557 oral solution | DRUG | The \[14C\]-GSK2269557 solution will be available with dosing strength of 800 µg, administered as single dose orally. It will be prepared by dissolving \[14C\]-GSK2269557 hemisuccinate salt (GSK2269557T) in water. |
Inclusion Criteria: * Subject must be 30 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vit...
GSK2269557 infusion is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development and has been studied in a completed trial involving healthy male volunteers in the United Kingdom.
GSK2269557 infusion is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for chronic obstructive pulmonary disease.
GSK2269557 infusion is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one early-stage trial. The study was a controlled, non-randomized trial in healthy volunteers.
GSK2269557 infusion has one completed clinical trial, NCT03315559, titled 'Absorption & Elimination of Radiolabelled GSK2269557'. This Phase 1 study enrolled 6 healthy male participants aged 30 years and older in the United Kingdom.
GSK2269557 infusion is a formulation of the investigational drug GSK2269557. The infusion form is being studied for chronic obstructive pulmonary disease in early clinical trials, with the completed study NCT03315559 evaluating its absorption and elimination.