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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02663089 | A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects | PHASE1 | COMPLETED | 6 | — | — | Feb 8, 2016 | Mar 17, 2016 | Oct 6, 2021 | 1 | United Kingdom |
The following PK parameter will be measured: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0 inf\])
The following PK parameter will be measured: Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC\[0-t\]).
The following PK parameter will be measured: maximum observed plasma concentration (Cmax)
The following PK parameter will be measured: time of occurrence of Cmax (Tmax)
The following PK parameter will be measured: terminal phase half-life (t1/2)
| Arm | Type | Description |
|---|---|---|
| [14C]-GSK961081 IV+GSK961081 inhalation; [14C]-GSK961081 oral | EXPERIMENTAL | On Day 1 of Treatment Period 1, after an overnight fast of at least 8 hours, each subject will receive \[14C\] GSK961081 4 micrograms (mcg) by IV infusion over 1 hour. Within 5 minutes after the start of infusion, subjects will take 1200 mcg non-radiolabelled GSK961081 by inhalation. After Treatment Period 1, there will be a washout of at least 2 weeks. On Day 1 of Treatment Period 2, after an overnight fast of at least 8 hours, each subject will take 200 mcg \[14C\]-GSK961081 as an oral solution. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK961081 solution for IV infusion | DRUG | Subjects will receive 10 mL of solution equivalent to 4 mcg of \[14C\]-GSK961081 (approximately 6.2 kilobecquerel \[kBq\]) intravenously as a single dose over 1 hour. |
| [14C]-GSK961081 oral solution | DRUG | Subjects will receive 10 mL of solution equivalent to 200 mcg of \[14C\]-GSK961081 (approximately 311 kBq) orally as a single dose with up to 250 mL of water. |
| GSK961081 dry powder for inhalation | DRUG | Subjects will receive single dose of 4 actuations of 300 mcg GSK961081 per actuation (1200 mcg GSK961081 total) as inhalation immediately after the start of infusion. |
Inclusion Criteria: * Between 30 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ...