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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Sungbuk-gu
    • Seoul, Sungbuk-gu, Korea, Republic of, 136-705
      • Korea University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Between 20 aged and 45 aged in healthy male adult
2. Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
3. Subject who sign on an informed consent form willingly
4. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C
Experimental: Group 2; B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C
Experimental: Group 3; C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C
Experimental: Group 4; A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C
Experimental: Group 5; B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C
Experimental: Group 6; C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)	Drug: CKD-519 50mg 2Tabs.; after taking Standard meal, CKD-519 50mg 2Tabs. administration.; Other Names: Drug A; Drug: CKD-519 100mg 1Tab.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; Other Names: Drug B; Drug: CKD-519 100mg 1Cap.; after taking Standard meal, CKD-519 100mg 1Cap. administration.; Other Names: Drug C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Tmax of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
AUClast of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
AUC0-∞ of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
t1/2 of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
CL/F of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Vd/F of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity	0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
Tmax of CKD-519 CETP Activity	0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
AUEC of CKD-519 CETP Activity	0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
EC50(half maximal effective concentration ) of CKD-519 CETP Activity	0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ji Young Kim, MD, PhD, Korea University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 17, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 148NF15010