Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fed Conditions

NCT06399068 | Completed Phase 1

• 1 other identifier: A84_09BE2208
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fed conditions

Conditions

Endocrine, Nutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-387, D484

  Area under the CKD-387, D484 concentration in blood-time curve from 0 to last sampling time (t)

  (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours

• Cmax of CKD-387, D484

  The maximum CKD-387, D484 concentration in blood sampling time (t)

  (Pre-dose) 0 hour, (Post-dose) 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours

Study Arms (2)

Reference-Test

EXPERIMENTAL

Drug: CKD-387; Drug: D484

Test- Reference

EXPERIMENTAL

Drug: CKD-387; Drug: D484

Interventions

CKD-387 DRUG

1 Tablet

Also known as: Test

Reference-Test; Test- Reference

D484 DRUG

1 Tablet

Also known as: Reference

Reference-Test; Test- Reference

Eligibility Criteria

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

You may qualify if:

• Healthy adults volunteers aged between 19 and 55 years old at the time of screening
• Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
• \* BMI = Weight(kg)/ Height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
• Individuals who signed an informed consent form approved by the Institutional Review Board of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and content
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
• Individuals with the ability and willingness to participate the entire study period

You may not qualify if:

• Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
• Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
• Individuals with the following laboratory test results at screening:
• \- Alanine aminotransferase or Aspartate aminotransferase \> 2x the upper limit of the normal range
• History of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
• Individuals who smoked more than 20 cigarettes per day within 6 months or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugs
• Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugs
• Following vital signs results at screening
• \- Sitting systolic blood pressure ≥ 150 mmHg or \< 90 mmHg and/or sitting diastolic blood pressure ≥100 mmHg or \<50 mmHg
• Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
• Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational drugs
• Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugs
• Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugs
• Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
• Individuals with hypersensitivity to investigational products or the investigational products ingredients

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Bumin Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic 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: January 22, 2024
• First Posted: May 3, 2024
• Study Start: September 19, 2022
• Primary Completion: September 29, 2022
• Study Completion: October 5, 2022
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)