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Completed

NCT Number: NCT02910635

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

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.

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Key information

Conditions

Abnormalities, Cardiovascular Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have given written informed consent and be able to comply with all study requirements
  • Males and females aged 18-55 at the time of informed consent
  • Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method
  • Males must be surgically sterile, abstinent or using an acceptable contraceptive method
  • The subject has a BMI of 19 to 32 kg/m^2 inclusive
  • Consumption of nicotine or nicotine-containing products for at least 6 months before Screening

Exclusion criteria

  • History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia
  • Abnormal screening ECG
  • Use of concomitant medications unless authorized by the Sponsor Medical Monitor
  • Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
  • Treatment with another Study Drug, biological agent, or device within one-month of Screening
  • Tests positive for drugs of abuse or cotinine
  • Considered unsuitable for inclusion by the Principal Investigator

Treatment and study plan

Volanesorsen

Drug

ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial

moxifloxacin

Drug

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Placebo

Drug

Primary outcomes

  1. Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)

    Time frame: 24 Hours

    ECG monitoring up to 24 hours post dose

Secondary outcomes

  1. Placebo corrected change from baseline heart rate (HR, PR and QRS)

    Time frame: 24 Hours

    ECG monitoring 24 hours post dose

Other outcomes

  1. Volanesorse plasma pharmacokinetics (PK)

    Time frame: 0 to 24 hours

    Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Collaborators

  • Akcea Therapeutics

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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