Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

NCT04676893 | Unknown Phase 1

• 1 other identifier: A99_02BE2002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-388, D418

  Area under the CKD-388/D418 concentration in blood-time curve from zero to final

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours

• Cmax of CKD-388, D418

  The maximum CKD-388/D418 concentration in blood sampling time t

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours

Study Arms (2)

Reference-Test

EXPERIMENTAL

Drug: D418 Tab.; Drug: CKD-388 Tab.

Test-Reference

EXPERIMENTAL

Drug: D418 Tab.; Drug: CKD-388 Tab.

Interventions

D418 Tab. DRUG

1T

Also known as: Reference

Reference-Test; Test-Reference

CKD-388 Tab. DRUG

1T

Also known as: Test

Reference-Test; Test-Reference

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
• Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
• \* BMI = Weight(kg)/ Height(m)2
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration
• Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail

You may not qualify if:

• History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
• Thiazolidinedione
• DPP-4 inhibitor
• Metformin
• Any clinically significant chronic medical illness.
• Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Individuals with one of the following laboratory test results in screening
• AST, ALT \> UNL (upper normal limit) x 3
• Creatinine clearance ≤ 80 mL/min
• In ECG result, QTc \> 450 msec
• hCG(+) (only women)
• Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ji-Young Park, Professor

CONTACT

+82-2-920-6288; jypark21@korea.ac.kr

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: December 18, 2020
• First Posted: December 21, 2020
• Study Start: February 26, 2021
• Primary Completion: May 11, 2021
• Study Completion: May 18, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)