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Also known as [14C]-GSK2269557 IV infusion
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 developed by GSK plc for chronic obstructive pulmonary disease (COPD). The specific formulation referenced as [14C]-GSK2269557 IV infusion is a radiolabeled intravenous version used in a Phase 1 clinical trial to study how the drug is absorbed and eliminated in the body.
GSK2269557 targets PIK3CD, also known as phosphoinositide 3-kinase delta. It acts as an inhibitor of this target. PIK3CD inhibition is being explored in respiratory conditions such as chronic obstructive pulmonary disease.
GSK2269557 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this investigational asset.
GSK2269557 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes a completed trial evaluating the absorption and elimination of radiolabeled GSK2269557.
GSK2269557 has been studied in one completed Phase 1 trial, NCT03315559, titled Absorption & Elimination of Radiolabelled GSK2269557. The trial enrolled 6 healthy male volunteers in the United Kingdom and was conducted in participants with chronic obstructive pulmonary disease. No active trials are currently listed.
Yes, [14C]-GSK2269557 IV infusion is an alternative name for GSK2269557 infusion. The [14C] label indicates a carbon-14 radiolabel used in a Phase 1 trial to track the drug's absorption and elimination. Both names refer to the same investigational compound.