Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

NCT04906109 | Completed Phase 1

• 1 other identifier: DA2803_BE_I
• Study Type: interventional
• Target: 96
• 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 DA-2803 in healthy subjects

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

• AUCt of DA-2803, Vemlidy

  Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final

  pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour

• Cmax of DA-2803, Vemlidy

  The maximum DA-2803/Vemlidy concentration in blood sampling time t

  pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour

Study Arms (2)

Reference-Test

EXPERIMENTAL

Drug: Vemlidy Tab; Drug: DA-2803 Tab

Test-Reference

EXPERIMENTAL

Drug: Vemlidy Tab; Drug: DA-2803 Tab

Interventions

Vemlidy Tab DRUG

1T

Also known as: Reference

Reference-Test; Test-Reference

DA-2803 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.
• Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
• BMI = Weight(kg)/ Height(m)2
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
• 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 trial

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.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
• 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 1.5
• Creatinine clearance ≤ 60 mL/min
• Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
• Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
• Individuals who cannot eat standard meal provided from clinical trial center.
• Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
• Individuals who had received a blood transfusion within 60 days prior to study drug administration.
• Exposure to any investigational drug within 6 months prior to the first IP administration.
• Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive 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: May 24, 2021
• First Posted: May 28, 2021
• Study Start: July 12, 2021
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)