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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426033
• Other study ID #: ISIS 681257-CS10
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2018
• Last updated: April 3, 2018
• Start date: December 15, 2017
• Est. completion date: February 25, 2018

Study information

• Verified date: April 2018
• Source: Akcea Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 25, 2018
• Est. primary completion date: February 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Elevated Lipoprotein(a)

Intervention

Drug:
• ISIS 681257
Xmg dose administered as a subcutaneous injection
• Warfarin
25mg tablet administered orally

Locations

Country	Name	City	State
Canada	Clinical Site	Mount Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Akcea Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.	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.	45 days
Secondary	Prothrombin Time will be measured by testing blood samples at each individual time point.	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.	Each day for days 1-7 and 15-21
Secondary	International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.	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.	Each day for days 1-7 and 15-21
Secondary	Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.	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.	Each day for days 1-7 and 15-21
Secondary	The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.	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.	Each day for days 1-10 and 15-45