Study S002154

An Exploratory Randomized, 2-Part, Single-blind, 2-Period Crossover Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Volunteers

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02802514
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: SINGLE
Status: TERMINATED
Enrollment: 5
Start: 2016-09-20
Primary completion: 2017-08-10
Lead sponsor: GlaxoSmithKline
Conditions: Diabetes Mellitus
Interventions: DRUG:Albiglutide 50mg; DRUG:Albiglutide matching placebo; DRUG:Exenatide 10microgram; DRUG:Exenatide placebo (saline)
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance Imaging (fMRI) Visual Nauseogenic Task [Up to Week 11]
Regional Cerebral Blood Flow (rCBF) by Functional MRI (fMRI)-Arterial Spin Labeling (ASL) [Up to Week 11]
Glutamate Concentration in Nausea-associated Brain Regions by Magnetic Resonance Spectroscopy (MRS) [Up to Week 11]
Gama-aminobutyric Acid (GABA) Concentration in Nausea-associated Brain Regions by MRS [Up to Week 11]

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