drugset / Trial / NCT01090661
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
RandomizedCrossoverQuadruple-blindTreatment
Summary
To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; \[2-hour infusion\]) supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.
Timeline
- Start
- 2010-03
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | Intravenous |
| Subject | mipomersen | Antisense oligonucleotide | 200 mg | Intravenous |
Indications
No indication recorded.