Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions

A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Hypertension and Dyslipidemia
• Intervention / Treatment: Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Detailed Description

To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • H+ Yangji Hospita

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 adults volunteers aged ≥19 years
2. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg BMI = Weight(kg)/ Height(m)2

3. Following vital signs results at screening

   • Systolic blood pressure: 90 mmHg to 139 mmHg
   • Diastolic blood pressure: 60 mmHg to 89 mmHg
4. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
5. Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, serology, urology etc.) and ECG etc. performed
6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
7. Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content

Exclusion Criteria:

1. Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
2. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
3. Individuals who donated whole blood within the 8 weeks, or blood components within 4 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational drugs
4. Individuals who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery

5. Individuals who meet the following condition with 1 month of the first administration of investigational drugs

   • Alcohol: Man-21 glasses/week, Woman-14 glasses/week (1 glass = soju 50mL or liquor 30mL or beer 250mL)
   • Smoking: 20 cigarettes/day

6. Patients with the following diseases

   • Patients with hypersensitivity to the main constituents or components of the investigational drug
   • Severe hepatic impairment, biliary atresia or cholestasis
   • Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
   • Diabetes mellitus
   • Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
   • Renal vascular hypertension patients
   • Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
   • Patients with myopathy or have a history of family or genetic history of myopathy
   • Hypothyroidism
   • If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
7. Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
8. Those who are deemed insufficient to participate in this clinical study by investigators
9. Woman who are pregnant or breastfeeding

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference-Test1-Test2	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference
Experimental: Reference-Test2-Test1	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference
Experimental: Test1-Reference-Test2	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference
Experimental: Test1-Test2-Reference	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference
Experimental: Test2-Reference-Test1	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference
Experimental: Test2-Test1-Reference	Drug: CKD-386(4) F1; 1 Tablet; Other Names: Test1; Drug: CKD-386(4) F2; 1 Tablet; Other Names: Test2; Drug: D013, D326, D337; D013 1 Tablet, D326 1Tablet, D337 1 Tablet; Other Names: Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-386	Area under the CKD-386 concentration in blood-time curve from 0 to t	0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-386	The maximum CKD-386 concentration in blood sampling time t	0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jaewoo Kim, M.D., Gwanak-gu, Seoul, South Korea, 08779

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: A83_09BE2219P

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