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Pharmacokinetics (PK) of [amount hidden] Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
Plain-language guide to NCT00819468: phase 1 non-randomized trial of Teduglutide (GLP-2 analog), 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00819468
- Phase
- phase 1
- Status
- completed
- Start
- 2007-07-26
- Completion (planned or actual)
- 2007-08-23
- Participants
- 24 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), other
- Conditions studied
- Hepatic Impairment
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Teduglutide (GLP-2 analog).
It had two arms (groups): Participants with Moderate Hepatic Impairment (experimental) and Healthy Volunteers (active comparator).
The registry classes the interventions as drug.
More on the Plan
Participants in both groups are matched up by sex, age, BMI, and renal function.
Who Took Part
24 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 16 inclusion and 13 exclusion criteria; among the exclusions: participated in any other investigational drug trial within 30 days prior to study entry; participants with impaired hepatic function (in addition to exclusion criteria 1-4):; participants with normal hepatic function (in addition to exclusion criteria 1-4.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Teduglutide (GLP-2 analog) study: the participants and staff both knew the treatment.
It started in 2007-07-26 with completion listed for 2007-08-23.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Researchers chose this as the main measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last). Maximum concentration (Cmax). Elimination Half-Life (t1/2).
It also tracked 1 secondary outcome, for example Number of participants with Adverse events (AEs).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Teduglutide (GLP-2 analog) in 24 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.
Our Notes on the Compound
Teduglutide (GLP-2 analog): A GLP-2 analog approved for short bowel syndrome (Gattex/Revestive); it helps the remaining gut absorb more and lowers IV nutrition needs.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.