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

NCT ID: NCT02894541

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-01-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-519 tablet 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

Group Type: EXPERIMENTAL

CKD-519 100mg

Intervention Type: DRUG

CKD-519 tablet 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

Group Type: EXPERIMENTAL

CKD-519 200mg

Intervention Type: DRUG

CKD-519 soft capsule 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

Group Type: EXPERIMENTAL

CKD-519 100mg

Intervention Type: DRUG

CKD-519 soft capsule 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

Group Type: EXPERIMENTAL

CKD-519 200mg

Intervention Type: DRUG

Interventions

CKD-519 100mg

Intervention Type: DRUG

CKD-519 200mg

Intervention Type: DRUG

CKD-519 100mg

Intervention Type: DRUG

CKD-519 200mg

Intervention Type: DRUG

Other Intervention Names

CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab); CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs); CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap); CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps)

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji Young Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University

Locations

Korea university medical center

Seoul, Sungbuk-gu, South Korea

Countries

South Korea

Other Identifiers

148FDI16004

Identifier Type: -

Identifier Source: org_study_id