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Trial record 9 of 734 for:    warfarin

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

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ClinicalTrials.gov Identifier: NCT03426033
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Akcea Therapeutics

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.

Condition or disease Intervention/treatment Phase
Elevated Lipoprotein(a) Cardiovascular Diseases Drug: ISIS 681257 Drug: Warfarin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : February 25, 2018
Actual Study Completion Date : February 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single dose of warfarin
Single dose of warfarin administered to obtain pharmacokinetic information.
Drug: Warfarin
25mg tablet administered orally

Experimental: Warfarin in combination with ISIS 681257
ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.
Drug: ISIS 681257
Xmg dose administered as a subcutaneous injection

Drug: Warfarin
25mg tablet administered orally




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426033


Locations
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Canada, Quebec
Clinical Site
Mount Royal, Quebec, Canada, H3P 3H5
Sponsors and Collaborators
Akcea Therapeutics

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Responsible Party: Akcea Therapeutics
ClinicalTrials.gov Identifier: NCT03426033     History of Changes
Other Study ID Numbers: ISIS 681257-CS10
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Warfarin
Anticoagulants