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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02666287 | GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV) | PHASE1 | COMPLETED | 48 | — | — | Jan 27, 2016 | Jun 3, 2016 | May 15, 2017 | 1 | United Kingdom |
The following PK parameter will be measured: AUC
The following PK parameter will be measured: Cmax
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: A,G/B/F/C,H/E/D,I with a washout period of 7 days between each treatment period administered via the ELLIPTA inhaler. Where Treatment A= BAT/FF 900/300 microgram (mcg) (3 inhalations of 300/100 mcg). Treatment B= BAT 900 mcg (3 inhalations of 300 mcg) concurrently with FF (lactose) 300 mcg (3 inhalations of 100 mcg) from separate inhalers. Treatment C= BAT 900 mcg (3 inhalations of 300 mcg). Treatment D= FF (lactose) 300 mcg (3 inhalations of 100 mcg). Treatment E= FF (magnesium stearate \[MgSt\]) 300 mcg (3 inhalations of 100 mcg). Treatment F= FF/VI 300/75 mcg (3 inhalations of 100 mcg/25 mcg). Treatment G= 7-day repeat doses: BAT/FF 300/100 mcg (1 inhalation). Treatment H= 7-day repeat doses: BAT 300 mcg (1 inhalation). Treatment I= 7-day repeat doses: FF (lactose) 100 mcg (1 inhalation). |
| Sequence 2 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: B/C,H/A,G/D,I/F/E with a washout period of 7 days between each treatment period. |
| Sequence 3 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: C,H/D,I/B/E/A,G/F with a washout period of 7 days between each treatment period. |
| Sequence 4 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: D,I/E/C,H/F/B/A,G with a washout period of 7 days between each treatment period. |
| Sequence 5 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: E/F/D,I/A,G/C,H/B with a washout period of 7 days between each treatment period. |
| Sequence 6 | EXPERIMENTAL | Each subject will receive all the 9 treatment regimens in the following order: F/A,G/E/B/D,I/C,H with a washout period of 7 days between each treatment period. |
| Name | Type | Description |
|---|---|---|
| BAT/FF | DRUG | BAT/FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose and its physical appearance is dry white powder. Second strip contains 100 mcg per blister of FF blended with lactose and its physical appearance is dry white powder. |
| BAT | DRUG | BAT is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose appear as dry white powder. Second strip contains lactose which appear as a dry white powder. |
| FF | DRUG | FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose which appear as dry white powder. |
| FF (MgSt) | DRUG | FF magnesium stearate is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose with magnesium stearate which appear as dry white powder. |
| FF/Vilanterol | DRUG | FF/Vilanterol is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 25 mcg per blister of vilanterol blended with lactose and magnesium stearate appear as dry white powder and second strip contains 100 mcg per blister of FF blended with lactose which appear as dry white powder. |
Inclusion Criteria: * Between 18 and 64 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 ...