NCT04334213

Brief Summary

A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D745 and D150

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

October 30, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 31, 2020

Last Update Submit

October 28, 2020

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of CKD-501, D745, D150

    Cmax,ss: Maximum concentration of drug in plasma at steady state

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

  • AUCtau,ss of CKD-501, D745, D150

    AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

Secondary Outcomes (4)

  • Cmin,ss of CKD-501, D745, D150

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

  • Tmax,ss of CKD-501, D745, D150

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

  • CLss/F of CKD-501, D745, D150

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

  • Fluctuation of CKD-501, D745, D150

    Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours

Study Arms (4)

Sequence 1

EXPERIMENTAL

Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days. Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).

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

Sequence 2

EXPERIMENTAL

Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days

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

Sequence 3

EXPERIMENTAL

Period 1: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).

Drug: D745, D150Drug: CKD-501, D745, D150

Sequence 4

EXPERIMENTAL

Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets).

Drug: D745, D150Drug: CKD-501, D745, D150

Interventions

CKD-501DRUG

QD, PO

Sequence 1Sequence 2
D745, D150DRUG

QD, PO

Sequence 3Sequence 4
CKD-501, D745, D150DRUG

QD, PO

Sequence 1Sequence 2Sequence 3Sequence 4

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteers aged between 19 and 55-year-old
  • Weight ≥ 55kg (men) or ≥ 50kg (women), with calculated body mass index(BMI) of 18.5 to 27.0 kg/m2
  • Women must meet one of the criteria written below:
  • Menopause (No menstruation for 2 years)
  • Sterilization (Hysterectomy or Oophorectomy, Tubal ligation etc.)
  • Men agree to contraception \& won't donate sperm during the participation of clinical trial
  • Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

You may not qualify if:

  • Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection
  • Those who have clinically significant dehydration or vulnerable to dehydration by poor oral intake
  • Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product
  • 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 below
  • AST, ALT \> 1.25 times higher than upper normal level
  • Total bilirubin \> 1.5 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, RPR
  • Under 5 min resting condition, systolic blood pressure \>150 mmHg or \<90 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim H, Kim CO, Park H, Park MS, Kim D, Hong T, Shin Y, Jin BH. Evaluation of pharmacokinetic interactions between lobeglitazone, empagliflozin, and metformin in healthy subjects. Transl Clin Pharmacol. 2023 Mar;31(1):59-68. doi: 10.12793/tcp.2023.31.e4. Epub 2023 Mar 23.

    PMID: 37034122DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Choon Ok Kim, M.D., 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 31, 2020

First Posted

April 6, 2020

Study Start

May 7, 2020

Primary Completion

August 5, 2020

Study Completion

August 5, 2020

Last Updated

October 30, 2020

Record last verified: 2020-03

Locations

KR(1)