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

Phase 1

Completed

• Conditions: Abnormalities, Cardiovascular
• Interventions: Drug: Placebo; Drug: Volanesorsen; Drug: Moxifloxacin

• Registration Number: NCT02910635
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-09
• Study Start: 2016-09-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Primary Completion: 2016-12-20
• Study Completion: 2016-12-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Intravenous (IV) single dose	Placebo	Administered as normal saline (0.9% Sodium Chloride)
Placebo Subcutaneous (SC) single dose	Placebo	Administered as normal saline (0.9% Sodium Chloride)
Volanesorsen, Intravenous (IV)	Volanesorsen	300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose
Volanesorsen, Subcutaneous (SQ)	Volanesorsen	300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose
Moxifloxacin Hydrochloride	Moxifloxacin	Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Primary Outcome Measures

Name	Time	Method
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)	24 Hours	ECG monitoring up to 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Placebo corrected change from baseline heart rate (HR, PR and QRS)	24 Hours	ECG monitoring 24 hours post dose

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States