Status:
COMPLETED
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel
Lead Sponsor:
Akcea Therapeutics
Conditions:
Elevated Lipoprotein(a)
Cardiovascular Diseases
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03392051
Start Date
December 28 2017
End Date
March 18 2018
Last Update
April 5 2018
Active Locations (1)
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1
Clinical Site
Mount Royal, Quebec, Canada, H3P 3H5