NCT01090661

A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects

A Randomized Double-Blinded Crossover Trial to Define the ECG Effects of Mipomersen (ISIS 301012) Using a Therapeutic and Supratherapeutic Dose Compared to Placebo and Moxifloxacin (a Positive Control) in Healthy Men and Women: A Thorough ECG Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be a randomized, double-blind, single-site, crossover study in healthy male and female subjects to determine if mipomersen administered as a single therapeutic (200 mg) SC and a single supra-therapeutic (200 mg) IV dose delays cardiac repolarization as determined by the measurement of QT/corrected QT (QTc) interval. A total of 60 healthy male and female subjects will be enrolled in this 4-way crossover study, randomly assigned to 1 of 8 treatment sequences, and cross over into 4 treatment periods where each subject will receive both a single SC injection and a single IV infusion during each period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	mipomersen sodium	200 mg of mipomersen intravenous (IV) (single dose)
DRUG	mipomersen sodium	200 mg of mipomersen subcutaneous (SC) (single dose)
DRUG	moxifloxacin hydrochloride (Avelox®)	400 mg of moxifloxacin intravenous (IV) single dose
DRUG	placebo	placebo intravenous (IV) single dose
DRUG	placebo	placebo subcutaneous (SC) single dose

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-22
• Last updated: 2016-08-03

Locations

1 site across 1 country: United States