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
Overview
- Phase
- Phase 1
- Intervention
- Clopidogrel
- Conditions
- Elevated Lipoprotein(a)
- Sponsor
- Akcea Therapeutics
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Clopidogrel Dosing
Multiple doses of Clopidogrel to obtain pharmacokinetic information.
Intervention: Clopidogrel
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.
Intervention: ISIS 681257
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.
Intervention: Clopidogrel
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
Time Frame: 55 days
The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.
Secondary Outcomes
- 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)
- 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)