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

Primary Purpose

Abnormalities, Cardiovascular

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Volanesorsen
Moxifloxacin
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abnormalities, Cardiovascular focused on measuring Thorough QTc, Therapeutic dose, supra therapeutic dose

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Covance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Volanesorsen, Intravenous (IV)

Volanesorsen, Subcutaneous (SQ)

Moxifloxacin Hydrochloride

Placebo Intravenous (IV) single dose

Placebo Subcutaneous (SC) single dose

Arm Description

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

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

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Administered as normal saline (0.9% Sodium Chloride)

Administered as normal saline (0.9% Sodium Chloride)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2016
Last Updated
January 13, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
Collaborators
Akcea Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02910635
Brief Title
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
Collaborators
Akcea Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormalities, Cardiovascular
Keywords
Thorough QTc, Therapeutic dose, supra therapeutic dose

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volanesorsen, Intravenous (IV)
Arm Type
Experimental
Arm Description
300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose
Arm Title
Volanesorsen, Subcutaneous (SQ)
Arm Type
Experimental
Arm Description
300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose
Arm Title
Moxifloxacin Hydrochloride
Arm Type
Active Comparator
Arm Description
Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
Arm Title
Placebo Intravenous (IV) single dose
Arm Type
Placebo Comparator
Arm Description
Administered as normal saline (0.9% Sodium Chloride)
Arm Title
Placebo Subcutaneous (SC) single dose
Arm Type
Placebo Comparator
Arm Description
Administered as normal saline (0.9% Sodium Chloride)
Intervention Type
Drug
Intervention Name(s)
Volanesorsen
Intervention Description
ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Description
Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)
Description
ECG monitoring up to 24 hours post dose
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Placebo corrected change from baseline heart rate (HR, PR and QRS)
Description
ECG monitoring 24 hours post dose
Time Frame
24 Hours
Other Pre-specified Outcome Measures:
Title
Volanesorse plasma pharmacokinetics (PK)
Description
Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)
Time Frame
0 to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Covance
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

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

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