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Completed

NCT Number: NCT02156544

Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519

The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, Seodaemun-gu, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 19 aged and 55 aged in healthy adult
  • Body weight more than 55kg in male, 50kg in female
  • Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
  • If female, must include more than one among the items
  • The menopause(there is no natural menses for at least 2 years)
  • Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
  • If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
  • Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent

Exclusion criteria

  • Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
  • An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood&urine laboratory test result) before 28 days the taking investigational Products.
  • Defined by the following laboratory parameters
  • AST, ALT>1.25* upper limit of normal range
  • Total bilirubin>1.5* upper limit of normal range
  • CPK>1.5* upper limit of normal range
  • eGFR(using by MDRD method)<60mL/min/1.73m2
  • Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break.
  • Drug abuse or have a history of drug abuse showes a positive for urine drug test.
  • Pregnant or lactating women.
  • A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
  • Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
  • Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
  • Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
  • Subject who treated with any investigational drugs within 60 days before the beginning of study treatment(However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life)
  • Previously donate whole blood within 60 days or component blood within 30 days.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

Treatment and study plan

CKD-519

Drug

Placebo

Drug

Primary outcomes

  1. Cmax of CKD-519

    Time frame: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  2. AUC0-last of CKD-519

    Time frame: 0(predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  3. AUC0-∞ of CKD-519

    Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  4. Tmax of CKD-519

    Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  5. t1/2 of CKD-519

    Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  6. CL/F of CKD-519

    Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  7. Vd/F of CKD-519

    Time frame: 0(Predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

Secondary outcomes

  1. CETP activity

    Time frame: 0(Predose), 0.5, 1, 2, 4, 8, 18, 24, 48, 72, 96, 120, 144, 168

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Dose-block Randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers

Acronym: CKD-519 FIH

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 5, 2014
Registry last updated
Sep 11, 2015

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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