NCT01028924

Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Teduglutide	subcutaneous (SC), single dose

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2009-12-09
• Last updated: 2012-05-07

Locations

1 site across 1 country: Germany