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

Phase 1CompletedNCT03392051

Akcea Therapeutics18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Elevated Lipoprotein(a)Cardiovascular Diseases

Interventions

ISIS 681257DRUG

Xmg dose administered as a subcutaneous injection

ClopidogrelDRUG

75mg tablet administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Site

Mount Royal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 55 days

Secondary Outcomes

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

Time frame: 55 days

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.

Time frame: 55 days

Data from ClinicalTrials.gov

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