Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects

NCT03175835 | Completed Phase 1

• 1 other identifier: 148DDI16023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Conditions

Dyslipidemias

Keywords

Dyslipidemia; CKD-519; Rosuvastatin; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))

  At steady state after multiple administration of CKD-519, Rosuvastatin

  0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

Secondary Outcomes (7)

• Pharmacokinetics (Peak plasma Concentration (Cmax,ss))

  0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

• Pharmacokinetics (Minimum plasma Concentration (Cmin,ss))

  0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

• Pharmacokinetics (Time to maximum plasma concentration (Tmax,ss))

  0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

• Pharmacokinetics (t1/2)

  0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

• Pharmacodynamics (CETP activity)

  0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26

Study Arms (1)

Rosuvastatin 20 mg & CKD-519 200 mg

EXPERIMENTAL

Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet)) Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets)) Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))

Drug: Rosuvastatin 20 mg; Drug: CKD-519 200 mg; Drug: Rosuvastatin 20 mg & CKD-519 200 mg

Interventions

Rosuvastatin 20 mg DRUG

Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1\~Day5

Also known as: Rosuvastatin 20 mg(20 mg X 1 tablet)

Rosuvastatin 20 mg & CKD-519 200 mg

CKD-519 200 mg DRUG

Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9\~Day21

Also known as: CKD-519 200 mg(100 mg X 2 tablets)

Rosuvastatin 20 mg & CKD-519 200 mg

Rosuvastatin 20 mg & CKD-519 200 mg DRUG

Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22\~Day26

Also known as: Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)

Rosuvastatin 20 mg & CKD-519 200 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between ≥ 20 and ≤ 45 years old
• Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
• Subjects to consents to use effective birth controls for at least 2 months following the last dose
• Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written

You may not qualify if:

• History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
• Any medical history that may affect drug absorption, distribution, metabolism and excretion
• Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics)
• Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase \> 3 fold upper normal limit(UNL)
• Severe renal failure(creatinin clearance \< 30 ml/min)
• Hypothyroidism or clinically significant test result
• Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders
• Any clinically significant chronic medical illness
• Any clinically significant hypotension or hypertension (systolic \< 100 mmHg/diastolic \< 60 mmHg or systolic \> 140 mmHg /diastolic \> 90 mmHg)
• Corrected QT interval(QTc) \>450msec on 12-lead ECG
• Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)
• Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)
• Use of any prescription drugs within 14 days prior to study drug administration
• Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium; CKD-519

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: June 5, 2017
• Study Start: May 8, 2017
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)