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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT01028924
First received: December 8, 2009
Last updated: May 4, 2012
Last verified: April 2010
  Purpose

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 Intervention Phase
Healthy
Drug: Teduglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • PK blood samples to investigate pharmacokinetics of teduglutide in plasma [ Time Frame: until 24 h post dose ] [ Designated as safety issue: No ]
  • PK blood samples to explore the concentration effect relationship on QT/QTc intervals [ Time Frame: until 24 h post dose ] [ Designated as safety issue: No ]
  • ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide [ Time Frame: within 14 days after trial medication administration ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028924

Locations
Germany
Nycomed GmbH
Konstanz, Germany, 78467
Sponsors and Collaborators
Nycomed
  More Information

No publications provided

Responsible Party: Head of Exploratory Clinical Development, Nycomed GmbH
ClinicalTrials.gov Identifier: NCT01028924     History of Changes
Other Study ID Numbers: TE-1777-102-EC
Study First Received: December 8, 2009
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
Thorough QTc-Study
Short Bowel Syndrome
Cardiac safety

ClinicalTrials.gov processed this record on September 18, 2014