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)

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 27, 2016

Primary Completion Date

June 3, 2016

Study Completion Date

June 3, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

BAT/FF

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.

DRUG

BAT

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.

DRUG

FF

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.

DRUG

FF (MgSt)

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.

DRUG

FF/Vilanterol

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.

Trial Locations (1)

NW10 7EW

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hammersmith Medicines Research

OTHER

lead

GlaxoSmithKline

INDUSTRY

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) | Biotech Hunter | Biotech Hunter