Clinical trial NCT02894541: Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519
Official title: A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Dyslipidemia
CKD-519
CETP inhibitor
Food Drug Interaction
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

Detailed description: A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Between 20 aged and 45 aged in healthy adult male
* Body weight more than 50, Body Mass Index between 18 and 29kg/m²
* 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
* 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:

* 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
* Defined by the following 12-lead ECG, QTc\>450msec
* 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
* Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
* Continuously taking caffeine(caffeine\>5 cups/day), drinking alcohol(alcohol\>210g/week), smoking excessive cigarettes(cigarette\>10cigarettes/day)
* Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)

Primary outcomes:
measure: Cmax of CKD-519
timeFrame: 0(predose)~168
measure: AUClast of CKD-519
timeFrame: 0(predose)~168
measure: Tmax of CKD-519
timeFrame: 0(predose)~168
measure: AUCinf of CKD-519
timeFrame: 0(predose)~168
measure: T1/2 of CKD-519
timeFrame: 0(predose)~168
measure: CL/F of CKD-519
timeFrame: 0(predose)~168
measure: Vd/F of CKD-519
timeFrame: 0(predose)~168
Secondary outcomes:
measure: Inhibition of CETP(Cholesteryl ester transfer protein) Activity
timeFrame: 0(predose)~168
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university medical center
state: Sungbuk-gu
Study officials:
affiliation: Korea University
name: Ji Young Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: