Drug Interaction Study of Simvastatin and Dabigatran

• Sponsor: Korea University Guro Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03728101
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Simvastatin, Dabigatran Etexilate	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
• Actual Study Start Date: Nov 16, 2018
• Actual Primary Completion Date: Dec 15, 2018
• Actual Study Completion Date: Dec 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax [24 hours]

   maximum plasma concentration

2. AUC [24 hours, zero to infinite]

   Area under the plasma concentration versus time curve

Secondary Outcome Measures

1. aPTT [24 hours]

   Activated partial thromboplastin time

2. TT [24 hours]

   Thrombin time

3. lag time [24 hours]

   thrombin generation assay

4. peak thrombin [24 hours]

   thrombin generation assay

5. velocity index [24 hours]

   thrombin generation assay

6. area under the curve [24 hours]

   thrombin generation assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

• Korea University Guro Hospital

Investigators

• Principal Investigator: Hyewon Chung, MD, PhD, Clinical Instructor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyewon Chung, Clinical instructor, Korea University Guro Hospital
• ClinicalTrials.gov Identifier: NCT03728101
• Other Study ID Numbers: SD-DDI
• First Posted: Nov 1, 2018
• Last Update Posted: Mar 12, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dabigatran; Simvastatin

Study Results

No Results Posted as of Mar 12, 2019