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

• Status: Completed
• Trial end date: 2018-02-25
• 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 a single dose of warfarin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akcea Therapeutics
• Treatments: Warfarin

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