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Completed

NCT Number: NCT03392051

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

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

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Key information

Conditions

Elevated Lipoprotein(a) Cardiovascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Mount Royal, Quebec, H3P 3H5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISIS 681257

Drug

Xmg dose administered as a subcutaneous injection

clopidogrel

Drug

75mg tablet administered orally

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Akcea Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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