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

• Status: Completed
• Trial end date: 2016-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Collaborator: Akcea Therapeutics
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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