Pharmacodynamic Drug Interaction Between Cilostazol and Statins (SMCCPT-100)

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer

The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cilostazol; Drug: Simvastatin; Drug: Rosuvastatin

Detailed Description

Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects aged 20 - 55 years
• A body mass index in the range 18.5 - 27 kg/m2
• Willingness to participate during the entire study period
• Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

• Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
• Active bleeding or bleeding tendency
• History of gastrointestinal disease or surgery possibly affecting drug absorption
• History of clinically significant drug hypersensitivity
• Use of medication within 7 days before the first dose
• Heavy drinker (>140 g/week)
• Whole blood donation during 60 days before the study
• Judged not eligible for study participation by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C -> C + S; cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Simvastatin; simvastatin qd for 7 days; Other Names: simvastatin (S); Zocor 40 mg
Experimental: C + S -> C; cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Simvastatin; simvastatin qd for 7 days; Other Names: simvastatin (S); Zocor 40 mg
Experimental: S -> S + C; simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Simvastatin; simvastatin qd for 7 days; Other Names: simvastatin (S); Zocor 40 mg
Experimental: C + S -> S; cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Simvastatin; simvastatin qd for 7 days; Other Names: simvastatin (S); Zocor 40 mg
Experimental: R -> C + R; rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Rosuvastatin; rosuvastatin qd for 7 days; Other Names: Rosuvastatin (R); Crestor 20 mg
Experimental: C + R -> R; cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2	Drug: Cilostazol; cilostazol bid for 7 days; Other Names: cilostazol (C); Plettal 100 mg; Drug: Rosuvastatin; rosuvastatin qd for 7 days; Other Names: Rosuvastatin (R); Crestor 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipid lowering effect	lipid panel	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-platelet effect	platelet aggregation test	7 days

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jae-wook Ko, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Antimetabolites; Neuroprotective Agents; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Rosuvastatin Calcium; Simvastatin; Cilostazol
• Other Study ID Numbers: 2011-11-004