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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin

NCT01214122

Pharmacokinetics Pharmacodynamics

WITHDRAWN PHASE1

Drug Interaction Study Between AZD3480 and Warfarin

NCT00689637

Alzheimer's Disease

COMPLETED PHASE1

Study to Investigate Safety and Tolerability of a Single Dose of AZD6482

NCT00688714

Antiplatelet Effect

COMPLETED PHASE1

Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)

NCT00508924

Coronary Artery Disease Angina, Unstable

COMPLETED PHASE2

Direct Oral Anticoagulants in Patients with Atrial Fibrillation (DOACs Vs Warfarin)

NCT03596502

Atrial Fibrillation Ischemic Stroke Systemic Embolization +3 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elevated Lipoprotein(a) Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single dose of warfarin

Single dose of warfarin administered to obtain pharmacokinetic information.

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

25mg tablet administered orally

Warfarin in combination with ISIS 681257

ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.

Group Type EXPERIMENTAL

ISIS 681257

Intervention Type DRUG

Xmg dose administered as a subcutaneous injection

Warfarin

Intervention Type DRUG

25mg tablet administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ISIS 681257

Xmg dose administered as a subcutaneous injection

Intervention Type DRUG

Warfarin

25mg tablet administered orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes