DRUG
Teduglutide
subcutaneous (SC), single dose
Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
Status
Completed
Phase
Phase 1
Enrollment
72
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 9, 2009
Study start
Nov 2009
Primary completion
Feb 2010
Study completion
Apr 2010
Results posted
Not reported
Registry updated
May 7, 2012
Outcomes
What the study measures.
Primary outcomes
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
Time frame · until 24 h post dose
Secondary outcomes
ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction
Time frame · until 24 h post dose
ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)
Time frame · until 24 h post dose
PK blood samples to investigate pharmacokinetics of teduglutide in plasma
Time frame · until 24 h post dose
PK blood samples to explore the concentration effect relationship on QT/QTc intervals
Time frame · until 24 h post dose
ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide
Time frame · within 14 days after trial medication administration
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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).
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Nycomed GmbH
Konstanz, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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