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

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

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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