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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
subcutaneous (SC), single dose
Nycomed GmbH
Konstanz, Germany
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
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
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