NCT02910635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

September 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

September 9, 2016

Last Update Submit

January 13, 2022

Conditions

Abnormalities, Cardiovascular

Keywords

Thorough QTc, Therapeutic dose, supra therapeutic dose

Outcome Measures

Primary Outcomes (1)

  • Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)

    ECG monitoring up to 24 hours post dose

    24 Hours

Secondary Outcomes (1)

  • Placebo corrected change from baseline heart rate (HR, PR and QRS)

    24 Hours

Other Outcomes (1)

  • Volanesorse plasma pharmacokinetics (PK)

    0 to 24 hours

Study Arms (5)

Volanesorsen, Intravenous (IV)

EXPERIMENTAL

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

Drug: Volanesorsen

Volanesorsen, Subcutaneous (SQ)

EXPERIMENTAL

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

Drug: Volanesorsen

Moxifloxacin Hydrochloride

ACTIVE COMPARATOR

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Drug: Moxifloxacin

Placebo Intravenous (IV) single dose

PLACEBO COMPARATOR

Administered as normal saline (0.9% Sodium Chloride)

Drug: Placebo

Placebo Subcutaneous (SC) single dose

PLACEBO COMPARATOR

Administered as normal saline (0.9% Sodium Chloride)

Drug: Placebo

Interventions

VolanesorsenDRUG

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

Volanesorsen, Intravenous (IV)Volanesorsen, Subcutaneous (SQ)
MoxifloxacinDRUG

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

Moxifloxacin Hydrochloride
PlaceboDRUG
Placebo Intravenous (IV) single dosePlacebo Subcutaneous (SC) single dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

ISIS 304801Moxifloxacin

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 22, 2016

Study Start

September 19, 2016

Primary Completion

December 20, 2016

Study Completion

December 20, 2016

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

US(1)