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Albiglutide Liquid Auto-injector · 1 trial · 1 indication
PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t).
PK blood samples will be collected for determination of albiglutide plasma concentrations AUC(0-inf).
PK blood samples will be collected for determination of albiglutide Cmax.
| Arm | Type | Description |
|---|---|---|
| Regimen AB | EXPERIMENTAL | Subjects will be receive Regimen A treatment in Session 1 followed by Regimen B treatment in Session 2. Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector. Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector. A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. |
| Regimen BA | EXPERIMENTAL | Subjects will be receive Regimen B treatment in Session 1 followed by Regimen A treatment in Session 2. Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector. Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector. A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. |
| Name | Type | Description |
|---|---|---|
| Albiglutide Liquid Auto-injector | DRUG | 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 |
| Albiglutide Lyophilized DCC Pen Injector | DRUG | 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 |
| Placebo Liquid Auto-injector | DRUG | 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. |
| Placebo Lyophilized DCC Pen injector | DRUG | 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. |
Inclusion Criteria: * Between 18 and 65 years of age. * Healthy. * Subject is a nonsmoker. * Subject's body mass index (BMI) is \>=18 kilogram/meter square (kg/m\^2) and \<=30 kg/m\^2 * Male or * Female Exclusion Criteria: * Alanine aminotransferase (ALT) \>1.5 x upper limit of normal range (ULN)...
Albiglutide Liquid Auto-injector is an investigational injectable formulation of albiglutide, a GLP1R agonist developed by GSK plc for the treatment of type 2 diabetes mellitus. It is designed to be delivered by an auto-injector device. The asset is in Phase 1 clinical development.
Albiglutide Liquid Auto-injector targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at that receptor. GLP1R agonism is the mechanism underlying its development for type 2 diabetes mellitus.
Albiglutide Liquid Auto-injector is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this liquid auto-injector formulation of albiglutide.
Albiglutide Liquid Auto-injector is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has one completed Phase 1 trial and no active trials.
Albiglutide Liquid Auto-injector has been studied in one completed Phase 1 trial, NCT02660736, titled Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects. The trial enrolled 59 healthy adult participants in the United States and was randomized, double-blind, and controlled.