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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

• Registration Number: NCT02623868
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-17
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CKD-519 50mg 2Tabs.	A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 1	CKD-519 100mg 1Tab.	A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 1	CKD-519 100mg 1Cap.	A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 2	CKD-519 50mg 2Tabs.	B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 2	CKD-519 100mg 1Tab.	B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 2	CKD-519 100mg 1Cap.	B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 3	CKD-519 50mg 2Tabs.	C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 3	CKD-519 100mg 1Tab.	C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 3	CKD-519 100mg 1Cap.	C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 4	CKD-519 50mg 2Tabs.	A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 4	CKD-519 100mg 1Tab.	A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 5	CKD-519 100mg 1Cap.	B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 6	CKD-519 50mg 2Tabs.	C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 6	CKD-519 100mg 1Tab.	C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 6	CKD-519 100mg 1Cap.	C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 4	CKD-519 100mg 1Cap.	A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 5	CKD-519 50mg 2Tabs.	B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Group 5	CKD-519 100mg 1Tab.	B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Primary Outcome Measures

Name	Time	Method
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	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
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
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
CL/F of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Cmax 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
Vd/F of CKD-519	0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
EC50(half maximal effective concentration ) of CKD-519 CETP Activity	0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Trial Locations

Locations (1)

Korea university medical center; 🇰🇷 Seoul, Sungbuk-gu, Korea, Republic of