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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Teduglutide


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teduglutide 5 mg<br>Treatment A, subcutaneous injection | Drug: Teduglutide<br>* subcutaneous (SC), single dose<br>|
| Experimental: Teduglutide 20 mg<br>Treatment B, subcutaneous injection | Drug: Teduglutide<br>* subcutaneous (SC), single dose<br>|
| Placebo Comparator: Placebo<br>subcutaneous injection | Drug: Teduglutide<br>* subcutaneous (SC), single dose<br>|
| Active Comparator: Moxifloxacin<br>400 mg, oral | Drug: Teduglutide<br>* subcutaneous (SC), single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval). |  | until 24 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thorough QTc-Study, Short Bowel Syndrome, Cardiac safety