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OpenTrials
Completed

NCT Number: NCT01028924

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

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.

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Key information

Conditions

Healthy Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nycomed GmbH

Konstanz, 78467, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Teduglutide

Drug

subcutaneous (SC), single dose

Primary outcomes

  1. 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 outcomes

  1. 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

  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)

    Time frame: until 24 h post dose

  3. PK blood samples to investigate pharmacokinetics of teduglutide in plasma

    Time frame: until 24 h post dose

  4. PK blood samples to explore the concentration effect relationship on QT/QTc intervals

    Time frame: until 24 h post dose

  5. ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide

    Time frame: within 14 days after trial medication administration

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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