A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.

NCT04810676 | Completed Phase 1

• 1 other identifier: A101_02BE2020
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUClast of CKD-383

  AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

• Cmax of CKD-383

  Cmax: Maximum plasma concentration of the drug

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

Secondary Outcomes (5)

• AUCinf of CKD-383

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

• Tmax of CKD-383

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

• T1/2 of CKD-383

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

• Vd/F of CKD-383

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

• CL/F of CKD-383

  0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)

Study Arms (2)

Sequence 1

EXPERIMENTAL

Peroid 1: CKD-501, D745, D150 -PO Peroid 2: CKD-383- PO

Drug: CKD-501, D745, D150; Drug: CKD-383

Sequence 2

EXPERIMENTAL

Peroid 1: CKD-383- PO Peroid 2: CKD-501, D745, D150 -PO

Drug: CKD-501, D745, D150; Drug: CKD-383

Interventions

CKD-501, D745, D150 DRUG

QD, PO

Sequence 1; Sequence 2

CKD-383 DRUG

QD, PO

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged between 19 and 55 years old.
• Weight ≥ 55kg(men) or ≥50kg(women),
• Calculated body mass index(BMI) of 18.5 to 27.0kg/m2
• Body Mass Index(BMI) = Weight(kg) / \[Height(m)\]2
• Women must meet one of the criteria written in below:
• Menopause (No menstruation for 2 years)
• Sterilization (hysterectomy or Oophorectomy, Tubal ligation etc.)
• Men agree to contraception and not to donate sperm during the participation of clinical trial.
• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand of the detailed description of this clinical trial.

You may not qualify if:

• Those who have a clinically significant disease or medical history of hepatic-biliary system issues, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor and/or mental health problems.
• Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.
• Those who receive intravenous administration of radioactive iodine contrast agents (for Urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48hours before the first administration of investigational product.
• Those who have severe urinary tract infection or have a past medical history of it.
• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• Those who have past medical history of gastrointestinal disorder(Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
• Those who have history of hypersensitivity to active pharmaceutical ingredient(Lobeglitazone, Empagliflozin, Metformin) or additives.
• Those who have the test results written in below:
• AST/ALT \> 1.25 times higher than upper normal level
• eGFR(estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
• "positive" or "reactive" test result of Hepatitis B \& C, HIV, PRP
• Under 5 min resting condition, systolic blood pressure \>150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg, or \<50mmHg
• Those who have a drug abuse history within one year or positive reaction on urine drug screening test
• Those who received following drugs, which may affect results of clinical trial and safety. Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration of the investigational drug. Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722, South Korea

Location

MeSH Terms

Interventions

lobeglitazone

Study Officials

• Min-soo Park, MD, PhD.

  Severance 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: March 11, 2021
• First Posted: March 23, 2021
• Study Start: April 16, 2021
• Primary Completion: May 20, 2021
• Study Completion: May 26, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

KR (1)