Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fed Conditions

Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: CKD-385; Drug: D744

Detailed Description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 high-dose in healthy volunteers under fed conditions

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min-Gul Kim; Phone Number: +82632593480; Email: mgkim@jbcp.kr

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • National University Hospital
    • Contact: Min-Gul Kim, Professor; Phone Number: +82632593480; Email: mgkim@jbcp.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults age≥19 years and age<55 years at the time of screening

2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg

   * BMI = Weight(kg)/ Height(m)2

3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
4. Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
5. Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria:

1. Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
2. Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug

3. Subject who shows the following values as a result of laboratory tests

   *ALT or AST > 2 times upper limit of normal range

4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
5. Subject who smokes more than one pack of cigarette a day within 6 months of screening
6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug

7. Subject who conform to the specific items below

   • systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
   • Severe bradycardia (less than 50 beats/minute)
8. Subject who has significant alcohol abuse or drug abuse within a year of screening
9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
11. Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
12. Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
13. Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
14. Subject who is not able to consume high-fat meal provided during the clinical trial
15. Subjects who were deemed inappropriate to participate in the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence1; Period 1: Reference drug(D744); Period 2: Test drug(CKD-385)	Drug: CKD-385; Test Drug; Drug: D744; Reference Drug
Experimental: Sequence2; Period 1: Test drug(CKD-385); Period 2: Reference drug(D744)	Drug: CKD-385; Test Drug; Drug: D744; Reference Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-385	Area under the concentration-time curve from time zero to time of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of CKD-385	Area under the concentration-time curve from zero up to infinity of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385	Time to maximum plasma concentration of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385	Terminal elimination half-life of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385	Apparent clearance of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385	Apparent Volume of Distribution of CKD-385	Pre-dose (0 hour), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Anticipated): June 4, 2021
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): August 6, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: A88_11BE2110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No