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NCT02660736 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT02660736 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 59 participants.
The verdict
NCT02660736, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Albiglutide Liquid Auto-injector
- DRUG Albiglutide Lyophilized DCC Pen Injector
- DRUG Placebo Liquid Auto-injector
- DRUG Placebo Lyophilized DCC Pen injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02660736
The ClinicalTrials.gov registry entry for NCT02660736 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Albiglutide Liquid Auto-injector is the first listed.
NCT02660736 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02660736 about?
NCT02660736 is a clinical study titled "Bioequivalence Study of Two Albiglutide Drug Products 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...
What is the current status of trial NCT02660736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2016-02. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02660736?
The interventions under investigation include: Albiglutide Liquid Auto-injector (DRUG), Albiglutide Lyophilized DCC Pen Injector (DRUG), Placebo Liquid Auto-injector (DRUG), Placebo Lyophilized DCC Pen injector (DRUG).
Who is sponsoring clinical trial NCT02660736?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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