NCT03426033

Brief Summary

This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

January 3, 2018

Last Update Submit

April 3, 2018

Conditions

Elevated Lipoprotein(a)Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.

    To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.

    Each day for days 1-10 and 15-45

Secondary Outcomes (5)

  • The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.

    45 days

  • Prothrombin Time will be measured by testing blood samples at each individual time point.

    Each day for days 1-7 and 15-21

  • International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.

    Each day for days 1-7 and 15-21

  • Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.

    Each day for days 1-7 and 15-21

  • The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.

    Each day for days 1-10 and 15-45

Study Arms (2)

Single dose of warfarin

EXPERIMENTAL

Single dose of warfarin administered to obtain pharmacokinetic information.

Drug: Warfarin

Warfarin in combination with ISIS 681257

EXPERIMENTAL

ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.

Drug: ISIS 681257Drug: Warfarin

Interventions

ISIS 681257DRUG

Xmg dose administered as a subcutaneous injection

Warfarin in combination with ISIS 681257
WarfarinDRUG

25mg tablet administered orally

Single dose of warfarinWarfarin in combination with ISIS 681257

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Motivated and available for duration of study and willing to adhere to protocol
  • Males who are unable to procreate or agree to contraception throughout study
  • Females who are postmenopausal or surgically sterile
  • BMI between 18.5 and 30 kg/m2
  • Weighing greater than or equal to 50kg
  • Normal lab results
  • No known diseases or significant findings on physical exam

You may not qualify if:

  • Females of childbearing potential
  • Reactions/infection at injection site
  • Hypersensitivity to any drugs or similar drugs to those used in the study
  • Conditions or disease that may interfere with study drug
  • Any significant diseases
  • Known history or familial history of bleeding disorders
  • Drug dependency or abuse
  • Illness within 28 days
  • Previous exposure to other investigational drug within 28 days
  • Blood donations within 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site

Mount Royal, Quebec, H3P 3H5, Canada

Location

Related Publications (1)

  • Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.

    PMID: 37070852DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

February 8, 2018

Study Start

December 15, 2017

Primary Completion

February 25, 2018

Study Completion

February 25, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)