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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 used for the treatment of Type 2 Diabetes Mellitus. It is being developed by GSK plc as a small molecule therapy for this metabolic condition. The drug is currently in Phase 1 clinical development, with one completed trial assessing its bioequivalence in healthy adult subjects.
Albiglutide Liquid Auto-injector is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for the treatment of Type 2 Diabetes Mellitus, with the asset currently in Phase 1 development.
Albiglutide Liquid Auto-injector is in Phase 1 clinical development. The drug is being studied for Type 2 Diabetes Mellitus, and it is not yet approved. It remains investigational, with one completed Phase 1 trial that evaluated bioequivalence in healthy subjects.
Albiglutide Liquid Auto-injector has one completed clinical trial, identified as NCT02660736. This Phase 1 study, titled 'Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects,' enrolled 59 participants in the United States. The trial was randomized, double-blind, and controlled, and it included healthy volunteers aged 18 years and older.
Albiglutide Liquid Auto-injector is a formulation of the drug albiglutide, delivered via an auto-injector device. The clinical trial NCT02660736 compares two albiglutide drug products, indicating that the liquid auto-injector is one version of albiglutide. However, the specific relationship between the two names is not further detailed in the available information.