Pharmacodynamic Study of Cilostazol in Healthy Volunteers (CiloMecT)

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Clopidogrel; Drug: Acetylsalicylic acid; Drug: Cilostazol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554721

21-13-102

2013-002633-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 4 patient groups

Group 1 (CYP2C19 Wild Type)

Experimental group

Description:

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)

Treatment:

Drug: Acetylsalicylic acid

Drug: Cilostazol

Group 2 (CYP2C19 Wild Type)

Experimental group

Description:

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)

Treatment:

Drug: Cilostazol

Drug: Clopidogrel

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

Experimental group

Description:

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)

Treatment:

Drug: Cilostazol

Drug: Clopidogrel

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

Experimental group

Description:

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)

Treatment:

Drug: Cilostazol

Drug: Clopidogrel