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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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