Study to Evaluate the Safety and Pharmacokinetics of CKD-331

NCT05335044 | Completed Phase 1

• 1 other identifier: A124_01BE2203
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence A

EXPERIMENTAL

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; Drug: EX5619

Sequence B

EXPERIMENTAL

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; Drug: EX5619

Interventions

CKD-331 DRUG

QD, PO

Sequence A; Sequence B

EX5619 DRUG

QD, PO

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• 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.
• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
• 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
• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• Those who are deemed insufficient to participate in this clinical study by investigators.
• Woman who are pregnant or breastfeeding.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H plus Yangji hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jaewoo Kim, M.D., PhD.

  Yanhji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: May 31, 2022
• Primary Completion: June 23, 2022
• Study Completion: July 12, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

KR (1)