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

N

Nycomed

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Teduglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028924
TE-1777-102-EC

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

72 participants in 4 patient groups, including a placebo group

Teduglutide 5 mg
Experimental group
Description:
Treatment A, subcutaneous injection
Treatment:
Drug: Teduglutide
Teduglutide 20 mg
Experimental group
Description:
Treatment B, subcutaneous injection
Treatment:
Drug: Teduglutide
Placebo
Placebo Comparator group
Description:
subcutaneous injection
Treatment:
Drug: Teduglutide
Moxifloxacin
Active Comparator group
Description:
400 mg, oral
Treatment:
Drug: Teduglutide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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