Drug Interaction Study of Simvastatin and Dabigatran

A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Simvastatin, Dabigatran Etexilate

Detailed Description

Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Dabigatran etexilate; Simvastatin + Dabigatran etexilate	Drug: Simvastatin, Dabigatran Etexilate; The subjects receive dabigatran etexilate with and without simvastatin administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	maximum plasma concentration	24 hours
AUC	Area under the plasma concentration versus time curve	24 hours, zero to infinite

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
aPTT	Activated partial thromboplastin time	24 hours
TT	Thrombin time	24 hours
lag time	thrombin generation assay	24 hours
peak thrombin	thrombin generation assay	24 hours
velocity index	thrombin generation assay	24 hours
area under the curve	thrombin generation assay	24 hours

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Hyewon Chung, MD, PhD, Clinical Instructor

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 9, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Simvastatin
• Other Study ID Numbers: SD-DDI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No