Drug Interaction Study of Simvastatin and Dabigatran | NCT03728101

Studies
Drug Interaction Study of Simvastatin and Dabigatran

NCT03728101

Sponsor

Korea University Guro Hospital

Status

Completed

Last Update Posted

Mar 12, 2019Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Simvastatin, Dabigatran Etexilate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2018Actual

Primary Completion Date

Dec 15, 2018Actual

Completion Date

Dec 15, 2018Actual

First Submitted Date

Oct 29, 2018

First Submission Date that Met QC Criteria

Oct 31, 2018

First Posted Date

Nov 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2019

Last Update Posted Date

Mar 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Experimental	Dabigatran etexilate Simvastatin + Dabigatran etexilate	Drug: Simvastatin, Dabigatran Etexilate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin, Dabigatran Etexilate	Drug	The subjects receive dabigatran etexilate with and without simvastatin administration	Single arm

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
aPTT	Activated partial thromboplastin time	24 hours
TT	Thrombin time	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic