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

NCT02156544 | Completed Phase 1

• 1 other identifier: 148HPS14001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (7)

• Cmax of CKD-519

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

• AUC0-last of CKD-519

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

• AUC0-∞ of CKD-519

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

• Tmax of CKD-519

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

• t1/2 of CKD-519

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

• CL/F of CKD-519

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

• Vd/F of CKD-519

  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

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

Study Arms (5)

CKD-519 25mg

EXPERIMENTAL

CKD-519 25mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 50mg

EXPERIMENTAL

CKD-519 50mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 100mg

EXPERIMENTAL

CKD-519 100mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 200mg

EXPERIMENTAL

CKD-519 200mg or placebo

Drug: CKD-519; Drug: placebo

CKD-519 400mg

EXPERIMENTAL

CKD-519 400mg or placebo

Drug: CKD-519; Drug: placebo

Interventions

CKD-519 DRUG

CKD-519 100mg; CKD-519 200mg; CKD-519 25mg; CKD-519 400mg; CKD-519 50mg

placebo DRUG

CKD-519 100mg; CKD-519 200mg; CKD-519 25mg; CKD-519 400mg; CKD-519 50mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

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

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

CKD-519

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Min-Su Park, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 11, 2015

Record last verified: 2014-05

Locations

KR (1)