A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants

What Was Tested

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

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as device and drug.

More on the Plan

This is a 2-period crossover study and consists of two cohorts.

Cohort 1 consists of participant's with greater than or equal to (\>=) 40.0 kilogram (kg) to lesser than or equal to (\<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (\>) 75.0 kg to \<= 120.0 kg of weight.

Participants in each cohort will be randomized to 1 of 2 treatment sequences AB or BA.

Randomization will be stratified by injection site (i.e., thigh, abdomen, and arm) within each cohort.

Who Took Part

The registry lists 64 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: An understanding, ability, and willingness to fully comply with study procedures and restrictions. Ability to voluntarily provide written, signed, and dated informed consent and assent as applicable to participate in the study. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: known or suspected intolerance or hypersensitivity to teduglutide, closely-related compounds, or any of the stated ingredients; known history of alcohol or other substance abuse within the last year prior to screening; pregnant or lactating female.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Teduglutide (GLP-2 analog) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Teduglutide (GLP-2 analog) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Teduglutide (GLP-2 analog) study: the participants and staff both knew the treatment.

It started in 2021-01-13 with completion listed for 2021-08-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide. Maximum Observed Plasma Concentration (Cmax) of Teduglutide. Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide.

It also tracked 13 secondary outcomes, for example Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site, Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site, Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide, Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide, Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide and Apparent Total Body Clearance (CL/F) of Teduglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teduglutide (GLP-2 analog) in 64 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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