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

NCT02623868 | Completed Phase 1

• 1 other identifier: 148NF15010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (6)

Group 1

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Group 2

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Group 3

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Group 4

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Group 5

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Group 6

EXPERIMENTAL

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.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

Interventions

CKD-519 50mg 2Tabs. DRUG

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

Also known as: Drug A

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

CKD-519 100mg 1Tab. DRUG

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

Also known as: Drug B

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

CKD-519 100mg 1Cap. DRUG

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

Also known as: Drug C

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea university medical center

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

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

CKD-519

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ji Young Kim, MD, PhD

  Korea University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: December 8, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

KR (1)