A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects

What Was Tested

This registered phase 4 trial tested Exenatide.

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).

It had four arms (groups): With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2 (experimental), Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2 (experimental), With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2 (experimental) and Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2 (experimental).

The registry classes the interventions as drug.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Between 18 and 50 years of age inclusive, at the time of signing the informed consent. Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. Pure right-handed based on Edinburgh Handedness Inventory. Motion Sickness Susceptibility Questionnaire (MSSQ) Screening score \>60 and mock fMRI nausea rating \>=2. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or.

The full record lists 5 inclusion and 42 exclusion criteria; among the exclusions: subject's body mass index (bmi) is \>=19 (kilogram per square meter)kg/m\^2 and =\<30 kg/m\^2; male or; capable of giving signed informed consent which includes compliance with the requirements and restrictions.

How the Study Was Run

Design: randomized, crossover and single-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2016-09-20 with completion listed for 2017-08-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance Imaging (fMRI) Visual Nauseogenic Task (time frame: Up to Week 11). Regional Cerebral Blood Flow (rCBF) by Functional MRI (fMRI)-Arterial Spin Labeling (ASL) (time frame: Up to Week 11). Glutamate Concentration in Nausea-associated Brain Regions by Magnetic Resonance Spectroscopy (MRS) (time frame: Up to Week 11).

It also tracked 18 secondary outcomes, for example Heart Rate Variability Using Autonomic Response Measures by MRI, Number of Participants With Abnormal Electrocardiogram (ECG) Intervals Using Autonomic Response Measures by MRI, Number of Participants With Abnormal Respiratory Rate Using Autonomic Response Measures by MRI, Number of Participants With Skin Conductance Level Using Autonomic Response Measures by MRI, Number of Participants With Abnormal Heart Rate for Session 1 and Number of Participants With Abnormal Heart Rate for Session 2.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 5 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.