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

NCT02910635 ↗

Phase 1 Completed 52 enrolled Ionis Pharmaceuticals, Inc. Akcea Therapeutics · collab
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start
2016-09-19
Primary completion
2016-12-20
Completion
2016-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg Oral
Subject Volanesorsen Antisense oligonucleotide 300 mg Intravenous

Indications

No indication recorded.