Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03315559 | Absorption & Elimination of Radiolabelled GSK2269557 | PHASE1 | COMPLETED | 6 | — | — | Nov 14, 2017 | Dec 22, 2017 | Mar 13, 2020 | 1 | United Kingdom |
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...