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

Cardiovascular Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392051
• Other study ID #: ISIS 681257-CS11
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2018
• Last updated: April 3, 2018
• Start date: December 28, 2017
• Est. completion date: March 18, 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 multiple doses of clopidogrel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 18, 2018
• Est. primary completion date: March 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 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
• Clopidogrel
75mg 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	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	The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.	55 days
Secondary	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	Safety will be assessed by summarizing the reported adverse events	55 days
Secondary	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	P2Y12 reaction units (PRUs) will be measured at each individual time point.	55 days