Clinical Trial to Evaluate the Drug Drug Interaction of CKD-501 and D308

NCT03616392 | Completed Phase 1

• 1 other identifier: 19DDI18013
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 trial to evaluate the drug drug interaction of CKD-501 and D308

Conditions

Diabetes Mellitus, Type II

Keywords

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

• (Part 1) AUCss,tau of D308

  Area under the curve of D308 at steady state

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 1) Css,max of D308

  Max Concentration of D308 at steady state

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 2) AUCss,tau of CKD-501

  Area under the curve of CKD-501 at steady state

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 2) Css,max of CKD-501

  Max Concentration of CKD-501 at steady state

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Secondary Outcomes (16)

• (Part 1) Css,min of D308

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 1) Css,av of D308

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 1) Tss,max of D308

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 1) t1/2 of D308

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

• (Part 1) CLss/F of D308

  Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Study Arms (4)

Part 1: Group 1(Treatment A/Treatment B)

EXPERIMENTAL

Period 1: Treatment A (D308 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

Drug: D308, CKD-501

Part 1: Group 2(Treatment B/Treatment A)

EXPERIMENTAL

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment A (D308 1T)/day for 5days, QD, PO

Drug: D308, CKD-501

Part 2: Group 1(Treatment C/Treatment B)

EXPERIMENTAL

Period 1: Treatment C (CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

Drug: D308, CKD-501

Part 2: Group 2(Treatment B/Treatment C)

EXPERIMENTAL

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment C (CKD-501 1T)/day for 5days, QD, PO

Drug: D308, CKD-501

Interventions

D308, CKD-501 DRUG

1. D308 2. CKD-501: Lobeglitazone sulfate 0.5mg

Part 1: Group 1(Treatment A/Treatment B); Part 1: Group 2(Treatment B/Treatment A); Part 2: Group 1(Treatment C/Treatment B); Part 2: Group 2(Treatment B/Treatment C)

Eligibility Criteria

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

You may qualify if:

• Healthy adult older than 19 years at the time of screening
• BMI 17.5\~30.5kg/m2 and body weight more than 55kg
• Subject who has no chronic disease within last 3 years and no symptoms or pathological findings
• Suitable subject who is determined to be suitable at the time of screening such as laboratory tests(hematology, blood chemistry, urinalysis, virus/bacteriological test, etc.), sign of vitality, electrocardiogram
• Subject who signed the written consent of the Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to the clinical trial
• Subject who has will and ability to participate in clinical trials

You may not qualify if:

• Subject who has a history of clinical significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or allergic diseases(except for asymptomatic seasonal allergies not treated at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
• Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption
• Clinical laboratory test results showing the following values
• \* ALT or AST \> 2 times upper limit of normal range
• Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)
• Those taking other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug
• Subject who has a systolic blood pressure of less than 100mmHg or more than 140mmHg or diastolic blood pressure of less than 60mmHg or more than 90mmHg of screening
• Subject who has significant alcohol abuse or drug abuse within a year of screening
• Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days prior to the first administration of clinical trial medication
• More than 20 smokers per day within six months of screening
• Those taking prescription or non-prescription drugs within 10days before the first administration of clinical trial medication
• Those who donated whole blood within 2 months or those who donated the components within 1 month before the first administration of the clinical trial drug
• Subject who has risk of serious or chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and may interfere with the interpretation of test results
• Patients who are known to be hypersensitive to the drug or its components
• Patients with severe heart failure or heart failure(New York Heart Association(NYHA) Class 3, 4 heart patients)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Related Publications (1)

• Jang K, Jeon JY, Moon SJ, Kim MG. Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Clin Ther. 2020 Feb;42(2):295-304. doi: 10.1016/j.clinthera.2020.01.003. Epub 2020 Jan 25.

  PMID: 31992459 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: July 8, 2018
• First Posted: August 6, 2018
• Study Start: July 25, 2018
• Primary Completion: September 17, 2018
• Study Completion: November 13, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)