Study to Evaluate the Safety and Pharmacokinetics of CKD-331

An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers

Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Study Overview

• Status: Completed
• Conditions: Hypertension and Dyslipidemia
• Intervention / Treatment: Drug: CKD-331; Drug: EX5619

Detailed Description

An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jaewoo Kim, M.D., PhD.; Phone Number: +82-70-4665-9193; Email: m3116@newyjh.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.

6. Those who exceed an alcohol and cigarette consumption than below criteria Alcohol

   • Man: 21 glasses/week
   • Woman: 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Smoking: 20 cigarettes/day
7. Those who have genetic problems such as galactose intolerance, Lapp lactose 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition	Drug: CKD-331; QD, PO; Drug: EX5619; QD, PO
Experimental: Sequence B; Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition	Drug: CKD-331; QD, PO; Drug: EX5619; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of CKD-331	Cmax: Maximum plasma concentration of the drug	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours
AUCt of CKD-331	AUCt: Area under the concentration-time curve from time zero to time	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jaewoo Kim, M.D., PhD., Yanhji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: A124_01BE2203

Drug and device information, study documents

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