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NCT02910635

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

Completed Phase 1 Last updated 28 January 2022
What this trial tests

Phase 1 trial testing Volanesorsen in Abnormalities, Cardiovascular in 52 participants. Completed in 20 December 2016.

Timeline
19 September 2016
Primary endpoint
20 December 2016
20 December 2016

Quick facts

Lead sponsorIonis Pharmaceuticals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposeother
Enrollment52
Start date19 September 2016
Primary completion20 December 2016
Estimated completion20 December 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Abnormalities, Cardiovascular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current RNA strategies in treating cardiovascular diseases.
    Chia SPS, Pang JKS, Soh BS. · · 2024 · cited 13× · PMID 38291757 · DOI 10.1016/j.ymthe.2024.01.028

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Other trials of Volanesorsen

Trials testing the same drug.

Other Ionis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02910635.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing