Drug Interaction Study of Simvastatin and Dabigatran

NCT03728101 | Completed Phase 1

• 1 other identifier: SD-DDI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  maximum plasma concentration

  24 hours

• AUC

  Area under the plasma concentration versus time curve

  24 hours, zero to infinite

Secondary Outcomes (6)

• aPTT

  24 hours

• TT

  24 hours

• lag time

  24 hours

• peak thrombin

  24 hours

• velocity index

  24 hours

Study Arms (1)

Single arm

EXPERIMENTAL

* Dabigatran etexilate * Simvastatin + Dabigatran etexilate

Drug: Simvastatin, Dabigatran Etexilate

Interventions

Simvastatin, Dabigatran Etexilate DRUG

The subjects receive dabigatran etexilate with and without simvastatin administration

Single arm

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between the ages of 19 and 50 years
• Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
• Subjects who agree with performing contraception during the study
• Subjects who agreed with written informed consent

You may not qualify if:

• Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
• Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug
• Creatinine clearance is below 60 ml/min
• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range
• Subjects who have clinically significant bleeding
• Subjects at risk of bleeding
• Subjects who took drugs which significantly interact with simvastatin or dabigatran prior to dosing
• Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing
• Participated in a previous clinical trial within 90 days prior to dosing
• Subjects with a history of alcohol abuse
• Subjects who are determined by investigator's decision as unsuitable for clinical trial participation

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Interventions

Simvastatin; Dabigatran

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hyewon Chung, MD, PhD

  Clinical Instructor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 1, 2018
• Study Start: November 16, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

KR (1)