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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide 5 mg | Experimental | Treatment A, subcutaneous injection |
|
| Teduglutide 20 mg | Experimental | Treatment B, subcutaneous injection |
|
| Placebo | Placebo Comparator | subcutaneous injection |
|
| Moxifloxacin | Active Comparator | 400 mg, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | subcutaneous (SC), single dose |
|
| 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 |
| 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) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed GmbH | Konstanz | 78467 | Germany |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
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| 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 |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |