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Pharmacodynamic Study of Cilostazol in Healthy Volunteers

NCT ID: NCT02554721

Last Updated: 2021-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-03-30

Brief Summary

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The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (CYP2C19 Wild Type)

Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Acetylsalicylic acid

Intervention Type DRUG

Group 2 (CYP2C19 Wild Type)

Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Group 3 (CYP2C19 heterozygous (*1/*2) )

Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Group 4 (CYP2C19 homozygous (*2/*2))

Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Interventions

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Cilostazol

Intervention Type DRUG

Acetylsalicylic acid

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Caucasian male subjects
* Able to read, to write and to fully understand German language
* Provision of written informed consent before screening and baseline
* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion Criteria

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
* Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
* Use of antibiotics within thirty (30) days prior to screening and until baseline visit
* Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
* Supine pulse rate \> 100 beats/min or \<50 beats/min
* Systolic blood pressure \<100 or \>140 mmHg
* Diastolic blood pressure \<50 or \>90 mmHg
* Concomitant use of any other medication including over-the-counter preparations
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osamu Sato

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

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Bad Krozingen, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013-002633-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21-13-102

Identifier Type: -

Identifier Source: org_study_id