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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2018-03-18

Brief Summary

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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

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Detailed Description

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Conditions

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Elevated Lipoprotein(a) Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clopidogrel Dosing

Multiple doses of Clopidogrel to obtain pharmacokinetic information.

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

75mg tablet administered orally

Clopidogrel in combination with ISIS 681257

Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.

Group Type EXPERIMENTAL

ISIS 681257

Intervention Type DRUG

Xmg dose administered as a subcutaneous injection

Clopidogrel

Intervention Type DRUG

75mg tablet administered orally

Interventions

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ISIS 681257

Xmg dose administered as a subcutaneous injection

Intervention Type DRUG

Clopidogrel

75mg tablet administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes