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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Teduglutide

• Registration Number: NCT01028924
• Lead Sponsor: Nycomed

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-02
• Status Verified: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Teduglutide 5 mg	Teduglutide	Treatment A, subcutaneous injection
Teduglutide 20 mg	Teduglutide	Treatment B, subcutaneous injection
Placebo	Teduglutide	subcutaneous injection
Moxifloxacin	Teduglutide	400 mg, oral

Primary Outcome Measures

Name	Time	Method
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).	until 24 h post dose

Secondary Outcome Measures

Name	Time	Method
ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction	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)	until 24 h post dose
PK blood samples to investigate pharmacokinetics of teduglutide in plasma	until 24 h post dose
PK blood samples to explore the concentration effect relationship on QT/QTc intervals	until 24 h post dose
ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide	within 14 days after trial medication administration

Trial Locations

Locations (1)

Nycomed GmbH; 🇩🇪 Konstanz, Germany