Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Albiglutide Liquid Auto-injector

Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose

DRUG

Albiglutide Lyophilized DCC Pen Injector

Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL

DRUG

Placebo Liquid Auto-injector

Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.

DRUG

Placebo Lyophilized DCC Pen injector

Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.

Trial Locations (1)

78744

GSK Investigational Site, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY