Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects

NCT05189288 | Completed Phase 1

• 1 other identifier: A99_03BE2122
• Study Type: interventional
• Target: 65
• 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

  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

D418 Tab. - CKD-388 Tab.

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

Test-Reference

EXPERIMENTAL

CKD-388 Tab. - D418 Tab.

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

You may qualify if:

• Healthy male volunteers, aged ≥ 19 years old at the time of screening.
• Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 at the time of screening.
• \* BMI = Weight(kg)/ Height(m)2
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

You may not qualify if:

• Those with clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and urogenesis system, mental/nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
• Those who have participated in other clinical trials or bioequivalence studies within 6 months of the first administration date and administered the investigational drug
• Those who donated whole blood within 8 weeks of the first dose, or donated component blood within 2 weeks, or received blood transfusion within 4 weeks
• Those who meet the following conditions within 1 month of the first administration date
• In the case of men, alcohol consumption in excess of 21 drinks/week on average
• For women, alcohol consumption in excess of 14 drinks/week on average
• (1 glass = 50 mL of soju or 30 mL of Western liquor or 250 mL of beer)
• Smoking in excess of 20 cigarettes per day on average
• A person who falls under any of the following
• Patients with hypersensitivity to this drug or any of its components
• Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• In the case of female volunteers, those who are pregnant or suspected of being pregnant or are lactating

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H plus Yangji 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

Study Officials

• Jaewoo Kim

  South Korea

  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: January 2, 2022
• First Posted: January 12, 2022
• Study Start: January 14, 2022
• Primary Completion: March 12, 2022
• Study Completion: April 15, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)