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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2016-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Abnormalities, Cardiovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Volanesorsen, Intravenous (IV)

300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose

Group Type EXPERIMENTAL

Volanesorsen

Intervention Type DRUG

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

Volanesorsen, Subcutaneous (SQ)

300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose

Group Type EXPERIMENTAL

Volanesorsen

Intervention Type DRUG

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

Moxifloxacin Hydrochloride

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Placebo Intravenous (IV) single dose

Administered as normal saline (0.9% Sodium Chloride)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Subcutaneous (SC) single dose

Administered as normal saline (0.9% Sodium Chloride)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Volanesorsen

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

Intervention Type DRUG

Moxifloxacin

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes