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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028924
First Posted: December 9, 2009
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
  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 (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

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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028924


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

Responsible Party: Head of Exploratory Clinical Development, Nycomed GmbH
ClinicalTrials.gov Identifier: NCT01028924     History of Changes
Other Study ID Numbers: TE-1777-102-EC
First Submitted: December 8, 2009
First Posted: December 9, 2009
Last Update Posted: May 7, 2012
Last Verified: April 2010

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