A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborator:
Ionis Pharmaceuticals, Inc.
Treatments:
Fluoroquinolones Mipomersen Moxifloxacin Norgestimate, ethinyl estradiol drug combination