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NCT02802514 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
A Phase 4 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT02802514 is a Phase 4 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 5 participants.
The verdict
NCT02802514, a Phase 4 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore the potential differences at the expected time of maximum concentration (Cmax) between a long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of healthy volunteers assessed by magnetic resonance imaging (MRI). This is a phase IV, 2-part, 2-period crossover (session), single dose, randomized, single blind (blinded to both the subject and the imaging evaluators analysing the MRI data), placebo- and active-controlled study in adult healthy volunteers who are susceptible to motion sickness. Part A and Part B are the same in design, both consisting of a screening stage, a dosing/assessment stage, and a follow-up visit. Data from Part A will inform progression, methods, and analysis plan for Part B. Each sequence includes three scanning visits: albiglutide plus scan, exenatide plus scan and an off-therapy -natural history scan with a 6-9 week washout period between the dosing scans. A total of 24 to 28 subjects will be randomized in the study (Part A and Part B). The cross over design is divided into 2 sessions and schedule is as follow, on Day 1 (either Session 1 (S1) or Session 2 (S2) per, if randomized) subject will under go an off-therapy MRI scan, on Day 5 subject will receive a single dose of 50 mg albiglutide or albiglutide placebo, and Day 8 subject will receive a single dose of 10 microgram exenatide or saline placebo followed by a post-dose MRI scan. At each session subject will receive only one active drug (albiglutide or exenatide).
Interventions
- DRUG Albiglutide 50mg
- DRUG Albiglutide matching placebo
- DRUG Exenatide 10microgram
- DRUG Exenatide placebo (saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-09-20 |
| Est. Completion | 2017-09-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02802514
The ClinicalTrials.gov registry entry for NCT02802514 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 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 50mg is the first listed.
NCT02802514 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02802514 about?
NCT02802514 is a clinical study titled "A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects". The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore the potential differenc...
What is the current status of trial NCT02802514?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2016-09-20. Estimated completion is 2017-09-07.
What interventions are being tested in trial NCT02802514?
The interventions under investigation include: Albiglutide 50mg (DRUG), Albiglutide matching placebo (DRUG), Exenatide 10microgram (DRUG), Exenatide placebo (saline) (DRUG).
Who is sponsoring clinical trial NCT02802514?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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