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

• Sponsor: Nycomed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01028924
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 14.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Teduglutide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teduglutide 5 mg Treatment A, subcutaneous injection	Drug: Teduglutide; subcutaneous (SC), single dose
Experimental: Teduglutide 20 mg Treatment B, subcutaneous injection	Drug: Teduglutide; subcutaneous (SC), single dose
Placebo Comparator: Placebo subcutaneous injection	Drug: Teduglutide; subcutaneous (SC), single dose
Active Comparator: Moxifloxacin 400 mg, oral	Drug: Teduglutide; subcutaneous (SC), single dose

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

3. PK blood samples to investigate pharmacokinetics of teduglutide in plasma [until 24 h post dose]

4. PK blood samples to explore the concentration effect relationship on QT/QTc intervals [until 24 h post dose]

5. ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide [within 14 days after trial medication administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nycomed GmbH	Konstanz		Germany	78467

Sponsors and Collaborators

• Nycomed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01028924
• Other Study ID Numbers: TE-1777-102-EC
• First Posted: Dec 9, 2009
• Last Update Posted: May 7, 2012
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Thorough QTc-Study; Short Bowel Syndrome; Cardiac safety
• Additional relevant MeSH terms: Teduglutide

Study Results

No Results Posted as of May 7, 2012