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

Phase 1

Completed

• Conditions: Elevated Lipoprotein(a); Cardiovascular Diseases
• Interventions: Drug: ISIS 681257; Drug: Clopidogrel

• Registration Number: NCT03392051
• Lead Sponsor: 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 multiple doses of clopidogrel

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-28
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-05
• Primary Completion: 2018-03-18
• Study Completion: 2018-03-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Clopidogrel in combination with ISIS 681257	ISIS 681257	Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.
Clopidogrel Dosing	Clopidogrel	Multiple doses of Clopidogrel to obtain pharmacokinetic information.
Clopidogrel in combination with ISIS 681257	Clopidogrel	Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.

Primary Outcome Measures

Name	Time	Method
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	55 days	The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.

Secondary Outcome Measures

Name	Time	Method
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	55 days	P2Y12 reaction units (PRUs) will be measured at each individual time point.
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	55 days	Safety will be assessed by summarizing the reported adverse events

Trial Locations

Locations (1)

Clinical Site; 🇨🇦 Mount Royal, Quebec, Canada