Pharmacodynamic Study of Cilostazol in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-03-30
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aspirin; Cilostazol; Clopidogrel; Ticlopidine

Criteria

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