A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391

A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391 and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Drug: CKD-391, QD, PO

Detailed Description

A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 and D337 in healthy adult volunteers

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hyeon Soo Park, M.D.; Phone Number: +82-10-6455-2016; Email: wefe6405@bumin.co.kr

Study Locations

• Korea, Republic of
  • Gangseo-gu
    • Seoul, Gangseo-gu, Korea, Republic of, 07590
      • Bumin Hospital(Seoul)
      • Contact: Hyeon Soo Park, M.D.; Phone Number: +82-10-6455-2016; Email: wefe6405@bumin.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult aged between 19 to 55 at screening
2. Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2
3. Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings
4. Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening
5. Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
6. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial

Exclusion Criteria:

1. 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
2. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
3. Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs
4. Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks
5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery

6. Patients with the following diseases

   • Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit
   • Patients with severe liver failure or biliary obstruction and bile congestion
   • Patients with muscular disease, rhabdomyolysis, or persons with a past history
   • Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs
   • Patients with renal impairment or a history of in and patients with severe renal dysfunction
   • Patients with a history of muscle toxicity to other statin drugs or fibrate drugs
7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
8. Those who have hypersensitivity to the main constituents or components of the investigational drug
9. Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests
10. Woman who are pregnant or breastfeeding
11. Those who are deemed insufficient to participate in clinical study by investigators

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: Sequence 1; Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition; Period 2: CKD-391 - A single oral dose of 1 tablet under fasting condition; Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition; Period 4: CKD-391 - A single oral dose of 1 tablet under fasting condition	Drug: Drug: CKD-391, QD, PO; Drug: CKD-331, D337 QD, PO
Experimental: Sequence 2; Period 1: CKD-391 - A single oral dose of 1 tablet under fasting condition; Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition; Period 3: CKD-391 - A single oral dose of 1 tablet under fasting condition; Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition	Drug: Drug: CKD-391, QD, PO; Drug: CKD-331, D337 QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	AUCt of CKD-391: Area under the concentration-time curve time zero to time	Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
Primary Outcome Measure	Cmax of CKD-391: Maximum plasma concentration of the drug	Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: CKD-391
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: A52_10BE2220

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