Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

What Was Tested

The trial (phase 1) is built around Teduglutide (GLP-2 analog).

The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval).

The trial will consist of a screening and a treatment phase of four treatment periods.

It had four arms (groups): one (experimental), one (experimental), Placebo (placebo comparator) and Moxifloxacin (active comparator).

Treatment A, subcutaneous injection.

Treatment B, subcutaneous injection.

Subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

72 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Healthy male or female volunteers. Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight \>50 kg (females) and \>60 kg (males).

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover 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.

Each person switched between Teduglutide (GLP-2 analog) and the comparison at some point, usually with a gap in between.

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 2009-11 with completion listed for 2010-02.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example PK blood samples to explore the concentration effect relationship on QT/QTc intervals and ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teduglutide (GLP-2 analog) in 72 people.

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.