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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623868
• Other study ID #: 148NF15010
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2015
• Last updated: January 17, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• CKD-519 50mg 2Tabs.
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
• CKD-519 100mg 1Tab.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
• CKD-519 100mg 1Cap.
after taking Standard meal, CKD-519 100mg 1Cap. administration.

Locations

Country	Name	City	State
Korea, Republic of	Korea university medical center	Seoul	Sungbuk-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	Tmax of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	AUClast of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	AUC0-8 of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	t1/2 of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	CL/F of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	Vd/F of CKD-519		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h	No
Primary	Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity		0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h	No
Primary	Tmax of CKD-519 CETP Activity		0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h	No
Primary	AUEC of CKD-519 CETP Activity		0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h	No
Primary	EC50(half maximal effective concentration ) of CKD-519 CETP Activity		0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h	No