Overview

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

Status:
Completed
Trial end date:
2018-03-18
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Akcea Therapeutics
Treatments:
Clopidogrel
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