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

Completed · Phase 1 · Has a placebo group

Conditions studied: Abnormalities, Cardiovascular

In brief

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.

Key facts

Study ID

NCT02910635

Run by

Ionis Pharmaceuticals, Inc.

People needed

52

Starts

2016-09-19

Expected to finish

2016-12-20

Last updated by the study team

2022-01-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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