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

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

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

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: D418 Tab.; Drug: CKD-388 Tab.

Detailed Description

To healthy subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.

2. Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2

   * BMI = Weight(kg)/ Height(m)2

3. 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
4. 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

Exclusion Criteria:

1. History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion.

4. 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
5. Any clinically significant chronic medical illness.
6. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

7. 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)
8. Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
9. Use of any prescription drugs within 14 days prior to study drug administration.
10. Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
11. History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
12. Individuals who cannot eat standard meal provided from clinical trial center.
13. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
14. Individuals who had received a blood transfusion within 30 days prior to study drug administration.
15. Exposure to any investigational drug within 6 months prior to the first IP administration.
16. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
17. Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
18. Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking.
19. Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
20. Pregnant or women who may be pregnant
21. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference-Test	Drug: D418 Tab.; 1T; Other Names: Reference; Drug: CKD-388 Tab.; 1T; Other Names: Test
Experimental: Test-Reference	Drug: D418 Tab.; 1T; Other Names: Reference; Drug: CKD-388 Tab.; 1T; Other Names: Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Anticipated): February 26, 2021
• Primary Completion (Anticipated): May 11, 2021
• Study Completion (Anticipated): May 18, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: A99_02BE2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No