NCT02910635

A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers

A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.

Conditions

• Abnormalities, Cardiovascular

Interventions

Type	Name	Description
DRUG	Volanesorsen	ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
DRUG	Moxifloxacin	Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
DRUG	Placebo

Timeline

• Start date: 2016-09-19
• Primary completion: 2016-12-20
• Completion: 2016-12-20
• First posted: 2016-09-22
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States