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
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
Treatment A, subcutaneous injection
Intervention: Teduglutide (Drug)
Teduglutide 20 mg
Treatment B, subcutaneous injection
Intervention: Teduglutide (Drug)
Placebo
subcutaneous injection
Intervention: Teduglutide (Drug)
Moxifloxacin
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)