Last reviewed · How we verify
A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will enable the use of a liquid product in a ready-to-use single dose auto-injector. To support the development of the liquid auto-injector product, this healthy volunteer bioequivalence study will be conducted to compare the liquid drug product to the currently available lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose, 2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial lyophilized drug product.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 59 |
| Start date | 2016-02 |
| Completion | 2016-08 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- Albiglutide Liquid Auto-injector
- Albiglutide Lyophilized DCC Pen Injector
- Placebo Liquid Auto-injector
- Placebo Lyophilized DCC Pen injector
Primary outcomes
- Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2 — Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t). - AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2 — Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations AUC(0-inf). - Peak plasma concentration (Cmax) for albiglutide in session 1 and 2 — Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide Cmax.
Countries
United States