Pharmacodynamic Drug Interaction Between Cilostazol and Statins

NCT01870466 | Completed Phase 1

• 1 other identifier: 2011-11-004
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• lipid lowering effect

  lipid panel

  7 days

Secondary Outcomes (1)

• anti-platelet effect

  7 days

Study Arms (6)

C -> C + S

EXPERIMENTAL

cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2

Drug: Cilostazol; Drug: Simvastatin

C + S -> C

EXPERIMENTAL

cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2

Drug: Cilostazol; Drug: Simvastatin

S -> S + C

EXPERIMENTAL

simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2

Drug: Cilostazol; Drug: Simvastatin

C + S -> S

EXPERIMENTAL

cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2

Drug: Cilostazol; Drug: Simvastatin

R -> C + R

EXPERIMENTAL

rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2

Drug: Cilostazol; Drug: Rosuvastatin

C + R -> R

EXPERIMENTAL

cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2

Drug: Cilostazol; Drug: Rosuvastatin

Interventions

Cilostazol DRUG

cilostazol bid for 7 days

Also known as: cilostazol (C); Plettal 100 mg

C + R -> R; C + S -> C; C + S -> S; C -> C + S; R -> C + R; S -> S + C

Simvastatin DRUG

simvastatin qd for 7 days

Also known as: simvastatin (S); Zocor 40 mg

C + S -> C; C + S -> S; C -> C + S; S -> S + C

Rosuvastatin DRUG

rosuvastatin qd for 7 days

Also known as: Rosuvastatin (R); Crestor 20 mg

C + R -> R; R -> C + R

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Cilostazol; Simvastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Jae-Wook Ko, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: June 6, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

KR (1)