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Completed

NCT Number: NCT02623868

Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea university medical center

Seoul, Sungbuk-gu, 136-705, South Korea

About this study

Open-label, Randomized, 3-period, 6-sequence, crossover study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 20 aged and 45 aged in healthy male adult
  • Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
  • Subject who sign on an informed consent form willingly
  • Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products

Exclusion criteria

  • Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
  • Have a acute disease within 28 days before the beginning of study treatment
  • Have a disease history that can effect drug absorption, distribution, metabolism, excretion
  • Have a clinically significant chronic disease
  • Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
  • Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
  • Subject treated ethical drug within 14 days before the beginning of study treatment
  • Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
  • Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
  • Cannot take standard Meal
  • Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
  • Blood transfusion within 30 days
  • Taking drugs have received any other investigational drug within 90 days prior to the first dosing
  • Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
  • Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
  • Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Treatment and study plan

CKD-519 50mg 2Tabs.

Drug

after taking Standard meal, CKD-519 50mg 2Tabs. administration.

Other names: Drug A

CKD-519 100mg 1Tab.

Drug

after taking Standard meal, CKD-519 100mg 1Tab. administration.

Other names: Drug B

CKD-519 100mg 1Cap.

Drug

after taking Standard meal, CKD-519 100mg 1Cap. administration.

Other names: Drug C

Primary outcomes

  1. Cmax of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  2. Tmax of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  3. AUClast of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  4. AUC0-∞ of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  5. t1/2 of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  6. CL/F of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  7. Vd/F of CKD-519

    Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  8. Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity

    Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  9. Tmax of CKD-519 CETP Activity

    Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  10. AUEC of CKD-519 CETP Activity

    Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  11. EC50(half maximal effective concentration ) of CKD-519 CETP Activity

    Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2015
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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