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

NCT03392051 | Completed Phase 1

• 1 other identifier: ISIS 681257-CS11
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Elevated Lipoprotein(a); Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects

  The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.

  55 days

Secondary Outcomes (2)

• Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects

  55 days

• Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects

  55 days

Study Arms (2)

Clopidogrel Dosing

EXPERIMENTAL

Multiple doses of Clopidogrel to obtain pharmacokinetic information.

Drug: Clopidogrel

Clopidogrel in combination with ISIS 681257

EXPERIMENTAL

Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.

Drug: ISIS 681257; Drug: Clopidogrel

Interventions

ISIS 681257 DRUG

Xmg dose administered as a subcutaneous injection

Clopidogrel in combination with ISIS 681257

Clopidogrel DRUG

75mg tablet administered orally

Clopidogrel Dosing; Clopidogrel in combination with ISIS 681257

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akcea Therapeutics: lead

Study Sites (1)

Clinical Site

Mount Royal, Quebec, H3P 3H5, Canada

Location

Related Publications (1)

• Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.

  PMID: 37070852 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: December 28, 2017
• Primary Completion: March 18, 2018
• Study Completion: March 18, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)