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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002118-12 | EudraCT Number |
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The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence ABC | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin |
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| Treatment sequence ACB | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn |
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| Treatment sequence BAC | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin |
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| Treatment sequence BCA | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin |
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| Treatment sequence CBA | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clazosentan | Drug | Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI) | From 1 hour pre-dose to 24 hour after the end of infusion |
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Inclusion Criteria:
General criteria
Study-specific criteria
Exclusion Criteria:
General criteria
Study-specific criteria
• History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Netherlands B.V. | Groningen | 9713 GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33389549 | Derived | Henrich A, Juif PE, Dingemanse J, Krause A. PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT. J Pharmacokinet Pharmacodyn. 2021 Apr;48(2):213-224. doi: 10.1007/s10928-020-09728-7. Epub 2021 Jan 2. |
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| ID | Term |
|---|---|
| C109641 | clazosentan |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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3-way cross-over Phase 1 study
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| Treatment sequence CAB | Experimental | Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin |
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| Placebo | Drug | Matching placebo infusion |
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| Moxifloxacin | Drug | Film-coated tablet containing 400 mg moxifloxacin |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |