NCT02900027

Brief Summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

August 23, 2016

Last Update Submit

May 18, 2018

Conditions

Elevated Triglycerides (TG)

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of single and multiple doses of IONIS- APOC-III-LRx - (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters)

    The safety and tolerability of IONIS- APOC-III-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS APOC-III-LRx will be compared with those from subjects dosed with placebo.

    Up to 183 days

Secondary Outcomes (4)

  • To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

    Up to 183 days

  • To evaluate the urine pharmacokinetics of single and multiple doses of IONIS¬-APOC-III-LRx

    Up to 183 days

  • To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

    Up to 183 Days

  • To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx

    Up to 183 days

Other Outcomes (7)

  • Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx

    Up to 183 days

  • Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx

    Up to 183 days

  • Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx

    Up to 183 days

  • +4 more other outcomes

Study Arms (2)

IONIS-APOC-III-LRx

EXPERIMENTAL

Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection

Drug: Placebo Comparator

Placebo (Normal Saline)

PLACEBO COMPARATOR

Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

Drug: APOC-III-L-Rx

Interventions

APOC-III-L-RxDRUG

Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection

Placebo (Normal Saline)
Placebo ComparatorDRUG

Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator

IONIS-APOC-III-LRx

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have given written informed consent and be able to comply with all study requirements
  • Healthy males or females aged 18-65 inclusive
  • Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
  • Males must be surgically sterile, abstinent or using an acceptable contraceptive method
  • BMI \< 35.0 kg/m2
  • Subjects must have Fasting TG ≥ 90 mg/dL or ≥ 200 mg/dL depending on Cohort assignment

You may not qualify if:

  • 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
  • Regular excessive use of alcohol within 6 months of Screening
  • Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
  • Smoking \> 10 cigarettes a day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioPharma Services

Toronto, Ontario, M9L 3A2, Canada

Location

Related Publications (1)

  • Alexander VJ, Xia S, Hurh E, Hughes SG, O'Dea L, Geary RS, Witztum JL, Tsimikas S. N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels. Eur Heart J. 2019 Sep 1;40(33):2785-2796. doi: 10.1093/eurheartj/ehz209.

    PMID: 31329855DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Janice Faulknor

    BioPharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CA(1)