Pharmacodynamic Study of Cilostazol in Healthy Volunteers

NCT02554721 | Completed Phase 1 Results

• 2 other identifiers: 21-13-1022013-002633-38
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Ex-vivo Inhibition Of Platelet Aggregation (IPA)

  The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on IPA was determined ex vivo in citrated platelet rich plasma (PRP) after stimulation of aggregation by low-level adenosine diphosphate (ADP) (5 micromolar \[uM\]) and arachidonic acid (AA) (500 milligrams/liter \[mg/L\]). Light transmission aggregometry (LTA) was used to measure residual aggregation (the percentage of aggregation 5 minutes after the addition of ADP or AA). Results are reported as the 95% confidence intervals for the reported geometric mean ratios (GMRs) (\[cilostazol+reference (ASA or clopidogrel)\]/reference) for IPA.

  Baseline, Visit 5 (Day 22-29)

Secondary Outcomes (1)

• Effects On Skin Bleeding Time (BT)

  Visit 5 (Day 22-29)

Study Arms (4)

Group 1 (CYP2C19 Wild Type)

EXPERIMENTAL

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)

Drug: Cilostazol; Drug: Acetylsalicylic acid

Group 2 (CYP2C19 Wild Type)

EXPERIMENTAL

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)

Drug: Cilostazol; Drug: Clopidogrel

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

EXPERIMENTAL

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)

Drug: Cilostazol; Drug: Clopidogrel

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

EXPERIMENTAL

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)

Drug: Cilostazol; Drug: Clopidogrel

Interventions

Cilostazol DRUG

Group 1 (CYP2C19 Wild Type); Group 2 (CYP2C19 Wild Type); Group 3 (CYP2C19 heterozygous (*1/*2) ); Group 4 (CYP2C19 homozygous (*2/*2))

Acetylsalicylic acid DRUG

Group 1 (CYP2C19 Wild Type)

Clopidogrel DRUG

Group 2 (CYP2C19 Wild Type); Group 3 (CYP2C19 heterozygous (*1/*2) ); Group 4 (CYP2C19 homozygous (*2/*2))

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Bad Krozingen, Germany

Location

MeSH Terms

Interventions

Cilostazol; Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Osamu Sato

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: August 1, 2015
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-09

Locations

DE (1)