A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

What Was Tested

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

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects.

It had eight arms (groups): cohort A (other), Cohort AR (other), Cohort C (other), Cohort D (other) and Cohort E (other).

The registry classes the interventions as drug.

More on the Plan

Healthy subjects are enrolled once they have been screened and it is determined they qualify.

They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

Who Took Part

The registry lists 95 actual participants took part.

It was open to people of any sex aged from 20 years up to 55 years.

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

Examples of who could join: Men and women between 20 and 55 years of age. BMI of 18-35 inclusive. Able to understand and sign informed consent form. Willing and able to be confined at the clinical research center 8.5 days. Women of child bearing potential with a negative pregnancy test at screening and check-in.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: donated 1 pint or more of blood/blood products within 56 days prior to study or received plasma within 7 days prior to study; pregnancy or become pregnant; participated in another investigational trial 30 days prior.

How the Study Was Run

Design: randomized, single-group and triple-blind.

The participants were allocated by chance, so the Teduglutide (GLP-2 analog) group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Teduglutide (GLP-2 analog), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-09-06 with completion listed for 2007-04-23.

It ran at 1 site in United States.

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teduglutide (GLP-2 analog) in 95 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.