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Completed

NCT Number: NCT03426033

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

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.

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Key information

Conditions

Elevated Lipoprotein(a) Cardiovascular Diseases

Age range

16 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

Warfarin

Drug

25mg tablet administered orally

Primary outcomes

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

    Time frame: Each day for days 1-10 and 15-45

    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.

Secondary outcomes

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

    Time frame: 45 days

    To evaluate the safety and tolerability of multiple doses of ISIS 681257 40 mg subcutaneous injections when coadministered with a single oral dose of warfarin in healthy adult subjects.

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

    Time frame: Each day for days 1-7 and 15-21

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

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

    Time frame: Each day for days 1-7 and 15-21

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

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

    Time frame: Each day for days 1-7 and 15-21

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

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

    Time frame: Each day for days 1-10 and 15-45

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

Sponsors and collaborators

Lead sponsor

Akcea Therapeutics

Industry

Registry information

Official study title

Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 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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