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Clinical Trials/NCT01028924
NCT01028924CompletedPhase 1

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

Nycomed1 site in 1 country72 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Nycomed
Enrollment
72
Locations
1
Primary Endpoint
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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).

Exclusion Criteria

  • Not provided

Arms & Interventions

Teduglutide 5 mg

Experimental

Treatment A, subcutaneous injection

Intervention: Teduglutide (Drug)

Teduglutide 20 mg

Experimental

Treatment B, subcutaneous injection

Intervention: Teduglutide (Drug)

Placebo

Placebo Comparator

subcutaneous injection

Intervention: Teduglutide (Drug)

Moxifloxacin

Active Comparator

400 mg, oral

Intervention: Teduglutide (Drug)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Nycomed
Sponsor Class
Industry

Study Sites (1)

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