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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894541
• Other study ID #: 148FDI16004
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2016
• Last updated: February 21, 2017
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CKD-519 100mg

• CKD-519 200mg

• CKD-519 100mg

• CKD-519 200mg

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		0(predose)~168
Primary	AUClast of CKD-519		0(predose)~168
Primary	Tmax of CKD-519		0(predose)~168
Primary	AUCinf of CKD-519		0(predose)~168
Primary	T1/2 of CKD-519		0(predose)~168
Primary	CL/F of CKD-519		0(predose)~168
Primary	Vd/F of CKD-519		0(predose)~168
Secondary	Inhibition of CETP(Cholesteryl ester transfer protein) Activity		0(predose)~168