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

Akcea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Elevated Lipoprotein(a); Cardiovascular Diseases

Treatments: Drug: ISIS 681257; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03426033

ISIS 681257-CS10

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Single dose of warfarin

Experimental group

Description:

Single dose of warfarin administered to obtain pharmacokinetic information.

Treatment:

Drug: Warfarin

Warfarin in combination with ISIS 681257

Experimental group

Description:

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

Treatment:

Drug: Warfarin

Drug: ISIS 681257