Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAT/FF · 1 trial · 1 indication
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 ...
BAT/FF is an investigational small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BAT/FF is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in early-stage clinical development for respiratory conditions.
BAT/FF is in Phase 1 clinical development. It has completed one Phase 1 trial and is not yet approved for any use. The drug remains investigational and is being evaluated for safety and pharmacokinetics.
BAT/FF has been studied in one completed Phase 1 trial, NCT02666287, which evaluated GSK961081 alone and with fluticasone furoate in healthy volunteers. The trial enrolled 48 participants and was conducted in the United Kingdom.
Yes, BAT/FF is also known as GSK961081. The completed Phase 1 trial NCT02666287 evaluated GSK961081 alone and in combination with fluticasone furoate in healthy volunteers for chronic obstructive pulmonary disease.