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

Abnormalities, Cardiovascular Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910635
• Other study ID #: ISIS 304801-CS13
• Status: Completed
• Phase: Phase 1
• Start date: September 19, 2016
• Est. completion date: December 20, 2016

Study information

• Verified date: January 2022
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 20, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormalities, Cardiovascular
• Cardiovascular Abnormalities

Intervention

Drug:
• Volanesorsen
ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
• Moxifloxacin
Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
• Placebo

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.	Akcea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Volanesorse plasma pharmacokinetics (PK)	Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)	0 to 24 hours
Primary	Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)	ECG monitoring up to 24 hours post dose	24 Hours
Secondary	Placebo corrected change from baseline heart rate (HR, PR and QRS)	ECG monitoring 24 hours post dose	24 Hours