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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02660736 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t).
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 |
What the finished NCT02660736 record still lists
NCT02660736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Albiglutide Liquid Auto-injector is the first listed.
NCT02660736 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02660736's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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