A First Time in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

June 9, 2014

Primary Completion Date

December 25, 2016

Study Completion Date

December 25, 2016

Conditions
Oedema, Pulmonary
Interventions
DRUG

GSK2798745 solution

Clear, colourless GSK2798745 (0.1 to 0.4mg) solution in aqueous citrate buffer with 4% captisol

DRUG

GSK2798745 suspension

Aqueous suspension of GSK2798745 (\>=0.5 mg)

DRUG

GSK2798745 capsule

White Opaque granule filled capsules of GSK2798745 (\>=0.5 mg)

DRUG

Placebo solution

Clear, colourless solution of aqueous citrate buffer with 4% captisol

DRUG

Placebo suspension

Visually matching aqueous suspension of hypromellose acetate succinate powder

DRUG

Placebo capsule

Matching white opaque placebo blend filled capsule

Trial Locations (2)

CB2 2GG

GSK Investigational Site, Cambridge

NW10 7EW

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02119260 - A First Time in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients | Biotech Hunter | Biotech Hunter