Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel

April 3, 2018 updated by: Akcea Therapeutics

Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects

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 multiple doses of clopidogrel

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Mount Royal, Quebec, Canada, H3P 3H5
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clopidogrel Dosing
Multiple doses of Clopidogrel to obtain pharmacokinetic information.
Drug: Clopidogrel
75mg tablet administered orally
Experimental: Clopidogrel in combination with ISIS 681257
Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.
Drug: ISIS 681257
Xmg dose administered as a subcutaneous injection
Drug: Clopidogrel
75mg tablet administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects
Time Frame: 55 days
The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.
55 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects
Time Frame: 55 days
Safety will be assessed by summarizing the reported adverse events
55 days
Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects
Time Frame: 55 days
P2Y12 reaction units (PRUs) will be measured at each individual time point.
55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akcea Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Actual)

March 18, 2018

Study Completion (Actual)

March 18, 2018

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 681257-CS11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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