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NCT02910635
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
Phase 1 trial testing Volanesorsen in Abnormalities, Cardiovascular in 52 participants. Completed in 20 December 2016.
20 December 2016
Quick facts
| Lead sponsor | Ionis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 52 |
| Start date | 19 September 2016 |
| Primary completion | 20 December 2016 |
| Estimated completion | 20 December 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Volanesorsen — full drug profile →
- Moxifloxacin (moxifloxacin) — full drug profile →
- Placebo
Conditions studied
- Abnormalities, Cardiovascular — all drugs for Abnormalities, Cardiovascular →
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):
-
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
Verify or expand the search:
- PubMed search for NCT02910635
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Volanesorsen
Trials testing the same drug.
- NCT02658175 — The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomic · Phase 3 · completed
- NCT02300233 — The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia · Phase 3 · completed
- NCT03544060 — Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) · no longer available
Other Ionis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
- NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02910635 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
- Last refreshed: 28 January 2022
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