A Thorough QT Study of Teduglutide in Healthy Subjects.

Hartmann M, Timmer W, Schultz A, Nave R, Luehmann R, Krause S, Lahu G, Scholpp J

Clinical pharmacology in drug development1 Apr 2012Cited by 3 (Europe PMC)

PMID27121220DOI10.1177/2160763x12438745PepBankPUB-27121220

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialSafety outcome
In healthy volunteers, QTcF curves after both teduglutide doses were almost superposable with placebo curves.
In plain wordsIn healthy volunteers, QTcF curves after both teduglutide doses were almost identical to placebo curves.
Peptide
Teduglutide
Outcome
Direction not reportedQTcF time course
Study
n = 72
Comparator
placebo
Outcome group
Heart function · Cardiovascular
Studied dose
5 and 20 mg · subcutaneous · single injectionAs given in this study (human).
Source sentences
Summary
Arithmetic mean curves of QTcF intervals over time of both doses of teduglutide and of placebo were almost superposable.
1 context sentence(design, population, supporting numbers)
Summary · context
Seventy-two healthy volunteers underwent 4 treatment periods in randomized order with a single subcutaneous injection of placebo, 5 and 20 mg teduglutide, and a single oral 400-mg dose of moxifloxacin.
Report a problemFND-2712122003
02HumanNon-randomized trialSafety outcome
In healthy volunteers, the upper one-sided confidence bound for QTcF change after teduglutide 5 mg was 3.0 ms.
In plain wordsIn healthy volunteers, the upper confidence bound for QTcF change after teduglutide 5 mg was 3.0 ms.
Peptide
Teduglutide
Outcome
Not applicableQTcF change confidence bound
Study
n = 72
Comparator
predose
Analysis
Primary
Outcome group
Heart function · Cardiovascular
Studied dose
5 mg · subcutaneous · single injectionAs given in this study (human).
Measurements
Upper 95% one-sided confidence bound
3 ms
5 mg
Source sentences
Summary
The observed upper bounds of the 95% one-sided confidence intervals were 3.0 ms (5 mg) and 4.5 ms (20 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary variable to investigate the effect on cardiac repolarization was the difference between QTcF after administration versus predose.
Summary · context
Seventy-two healthy volunteers underwent 4 treatment periods in randomized order with a single subcutaneous injection of placebo, 5 and 20 mg teduglutide, and a single oral 400-mg dose of moxifloxacin.
Report a problemFND-2712122001
03HumanNon-randomized trialSafety outcome
In healthy volunteers, the upper one-sided confidence bound for QTcF change after teduglutide 20 mg was 4.5 ms.
In plain wordsIn healthy volunteers, the upper confidence bound for QTcF change after teduglutide 20 mg was 4.5 ms.
Peptide
Teduglutide
Outcome
Not applicableQTcF change confidence bound
Study
n = 72
Comparator
predose
Analysis
Primary
Outcome group
Heart function · Cardiovascular
Studied dose
20 mg · subcutaneous · single injectionAs given in this study (human).
Measurements
Upper 95% one-sided confidence bound
4.5 ms
20 mg
Source sentences
Summary
The observed upper bounds of the 95% one-sided confidence intervals were 3.0 ms (5 mg) and 4.5 ms (20 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary variable to investigate the effect on cardiac repolarization was the difference between QTcF after administration versus predose.
Summary · context
Seventy-two healthy volunteers underwent 4 treatment periods in randomized order with a single subcutaneous injection of placebo, 5 and 20 mg teduglutide, and a single oral 400-mg dose of moxifloxacin.
Report a problemFND-2712122002
04HumanNon-randomized trialSafety outcome
In healthy volunteers receiving teduglutide, no safety concerns were identified.
In plain wordsIn healthy volunteers receiving teduglutide, the study identified no safety concerns.
Peptide
Teduglutide
Outcome
Not applicableSafety concerns
Study
n = 72
Outcome group
Adverse events · Whole body
Studied dose
5 and 20 mg · subcutaneous · single injectionAs given in this study (human).
Source sentences
Summary
No safety concerns were identified.
1 context sentence(design, population, supporting numbers)
Summary · context
Seventy-two healthy volunteers underwent 4 treatment periods in randomized order with a single subcutaneous injection of placebo, 5 and 20 mg teduglutide, and a single oral 400-mg dose of moxifloxacin.
Report a problemFND-2712122004
05HumanNon-randomized trialSafety outcome
In healthy volunteers, teduglutide treatment was well tolerated.
In plain wordsIn healthy volunteers, teduglutide treatment was well tolerated.
Peptide
Teduglutide
Outcome
Not applicableTolerability
Study
n = 72
Outcome group
Adverse events · Whole body
Studied dose
5 and 20 mg · subcutaneous · single injectionAs given in this study (human).
Source sentences
Summary
Treatment with teduglutide was well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
Seventy-two healthy volunteers underwent 4 treatment periods in randomized order with a single subcutaneous injection of placebo, 5 and 20 mg teduglutide, and a single oral 400-mg dose of moxifloxacin.
Report a problemFND-2712122005

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

Keywords

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