Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CKD-519 100mg; Drug: CKD-519 200mg

• Registration Number: NCT02894541
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-519 tablet 100mg	CKD-519 100mg	CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
CKD-519 tablet 200mg	CKD-519 200mg	CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
CKD-519 soft capsule 100mg	CKD-519 100mg	CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
CKD-519 soft capsule 200mg	CKD-519 200mg	CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal

Primary Outcome Measures

Name	Time	Method
Tmax of CKD-519	0(predose)~168
CL/F of CKD-519	0(predose)~168
Cmax of CKD-519	0(predose)~168
AUCinf of CKD-519	0(predose)~168
T1/2 of CKD-519	0(predose)~168
AUClast of CKD-519	0(predose)~168
Vd/F of CKD-519	0(predose)~168

Secondary Outcome Measures

Name	Time	Method
Inhibition of CETP(Cholesteryl ester transfer protein) Activity	0(predose)~168

Trial Locations

Locations (1)

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