Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-828 in Healthy Subjects

An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between Administration of CKD-828 and Administration of D064,D701 in Healthy Adults

Exploratory Trial to Evaluate the Pharmacokinetic Properties and Safety of CKD-828 in Healthy Subjects

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: D064+D701; Drug: CKD-828 Formulation 1; Drug: CKD-828 Formulation 2

Detailed Description

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-828 and administration of D064, D701 in healthy adults

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan-si, Korea, Republic of
    • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male volunteers, aged ≥ 19 years old at the time of screening.
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5 kg/m2 and weighing 55 kg or more
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
4. Clinical laboratory tests (hematology tests, blood chemistry tests, urinalysis, serological tests, etc.) conducted by the principal investigator (or the investigator who has been delegated) according to the characteristics of the drug and screening tests such as vital signs and electrocardiogram tests Result Those who are judged to be suitable as test subjects
5. Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed
6. After the first administration of the clinical trial drug, for up to 14 days after the last administration of the investigational drug, you, your spouse, or your partner must agree to maintain the use of an appropriate medically acceptable method of contraception* except for hormonal contraceptives and not donate sperm or eggs ruler
7. Those who have the ability and willingness to participate during the entire examination period

Exclusion Criteria:

1. A history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history of calculus, impacted teeth, wisdom teeth, etc.) or evidence one who has
2. Those with a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery (except simple appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug absorption ruler

3. A person who shows the following values as a result of conducting a clinical laboratory test

   - ALT or AST > 2 times the upper limit of the normal range

4. Smokers who smoked more than 20 cigarettes a day within 6 months of screening
5. Those who have taken other clinical investigational drugs or bioequivalence investigational drugs within 6 months before the first administration of the clinical investigational drug

6. Those who meet the following as a result of measuring vital signs at screening

   • Those who have a systolic blood pressure of less than 90 mmHg or more than 140 mmHg or a diastolic blood pressure of less than 60 mmHg or more than 90 mmHg in the sitting position
   • Severe bradycardia (less than 50 beats/min)

7. Those with a history of regular alcohol intake within 1 month of screening

   • Over 14 drinks/Week for women
   • More than 21 drinks/Week for men
8. A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of the clinical trial drug
9. Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of clinical trial drugs
10. Those who have donated whole blood within 2 months before the first administration of the clinical trial drug, donated component blood within 1 month, received blood transfusion within 1 month, or have plans for the trial during the clinical trial period
11. Those who are judged by the principal investigator (or the person in charge of the test who has been delegated) for reasons other than the above selection/exclusion criteria and are judged unsuitable for participation in this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D064+D701 Period 2: Test1 Period 3: Test2	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2
Experimental: Sequence 2; Period 1: Test2 Period 2: D064+D701 Period 3: Test1	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2
Experimental: Sequence 3; Period 1: Test1 Period 2: Test2 Period 3: D064+D701	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2
Experimental: Sequence 4; Period 1: Test2 Period 2: Test1 Period 3: D064+D701	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2
Experimental: Sequence 5; Period 1: Test1 Period 2: D064+D701 Period 3: Test2	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2
Experimental: Sequence 6; Period 1: D064+D701 Period 2: Test2 Period 3: Test1	Drug: D064+D701; Reference; Drug: CKD-828 Formulation 1; Test 1; Drug: CKD-828 Formulation 2; Test 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-828, D064+D701	Area under the CKD-828, D064+D701 concentration in blood-time curve from zero to final	Pre-dose(0hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Cmax of CKD-828, D064+D701	Area under the CKD-828, D064+D701 concentration in blood-time curve from zero	Pre-dose(0hour), post-dose 0.25, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Mingi Kim, M.D., Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: A30_16BE2215P

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