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

NCT02910635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-01-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Akcea Therapeutics

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02910635 on ClinicalTrials.gov