Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)

Dyslipidemia Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, 3-treatment, 3-period, 6-sequence Crossover Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519 After Oral Administration in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484482
• Other study ID #: 148FDI15009
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2015
• Last updated: December 4, 2015
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• 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

The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Between 19 aged and 55 aged in healthy adult

2. Body weight more than 55kg in male, 50kg in female

3. Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)

4. 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)

5. 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

6. 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

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc.), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, haemato-oncology disease, cardiovascular system(heart failure, etc.) or mental illness, or a history of mental disease.

2. Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)

3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.

4. 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.

5. Defined by the following laboratory parameters

• AST(Aspartate aminotransferase), ALT(Alanine aminotransferase)>1.25* upper limit of normal range

• Total bilirubin>1.5* upper limit of normal range

• CPK(Creatine phosphokinase)>1.5* upper limit of normal range

• eGFR(Estimated Glomerular Filtration Rate, using by MDRD(Modification of Diet in Renal Disease) method)<60 mL/min/1.73m2

6. Sitting SBP(Systolic Blood Pressure )>150 mmHg or <90 mmHg, sitting DBP(Diastolic Blood Pressure )>100 mmHg or 50 mmHg , after 5 minutes break.

7. Drug abuse or have a history of drug abuse shows a positive for urine drug test.

8. Pregnant or lactating women.

9. A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)

10. Subject takes ethical drug or herbal medicine within 14 days, OTC(Over The Counter Drug) 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

11. Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30days.

12. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1 liter per a day or more within 7days before the beginning of study treatment)

13. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment.

14. Previously donate whole blood within 60 days or component blood within 30days.

15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• CKD-519 200mg / Fasting, Standard Meal, High Fat Meal

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-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		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	AUC0-8 of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	Tmax of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	T1/2 of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	CL/F(Clearance/Bioavailability) of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Primary	Vd/F of CKD-519		0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No
Secondary	Inhibition of CETP(Cholesteryl ester transfer protein) Activity		0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168	No