Effect of Teduglutide on Gastric Emptying in Healthy Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Teduglutide (GLP-2 analog).

It had two arms (groups): Placebo (placebo comparator) and teduglutide (experimental).

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Completed the screening process within 30 days prior to check in. Adult males or females age 18 to 45 years in good health as determined by medical history, physical examination, ECG, and laboratory tests.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: allergy or sensitivity to acetaminophen; history of structural abnormality or pathology of the gi tract or diseases/conditions which affect gi motility including the following:.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Teduglutide (GLP-2 analog) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Teduglutide (GLP-2 analog).

Those kept unaware of assignments: participant and investigator.

It started in 2010-09-28 with completion listed for 2010-11-08.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): PK log-transformed parameters AUC and CMax (time frame: Day 10).

It also tracked 2 secondary outcomes, for example AUC for each GI blood markers and CMax.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teduglutide (GLP-2 analog) in 36 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.