Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers

A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers

This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Viread 300mg; Drug: DA-2802 319mg

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Clinical Trial Center, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age between 20 to 50, healthy male subjects(at screening)
• Body weight over 55kg, BMI between 18.0 - 27.0
• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

• Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)
• Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
• Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread
• Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics
• exceed 1.5 times the normal range of AST, ALT at screening test before randomization
• history of drug abuse, or a positive urine drug screen
• having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
• Participation in any other clinical trial involving investigational drugs within 3 months
• Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
• Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
• Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)
• Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods
• Volunteers who are not using adequate contraception methods or have a pregnancy plan
• volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study
• any condition that, in the view of the investigator, would interfere with study participation

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: Viread → DA-2802; Viread 300mg(Tenofovir disoproxil fumarate); DA-2802 319mg(Tenofovir disoproxil orotate)	Drug: Viread 300mg; single dose administration after 10hr fasting; Other Names: Tenofovir disoproxil fumarate; Drug: DA-2802 319mg; single dose administration after 10hr fasting; Other Names: Tenofovir disoproxil orotate
Experimental: DA-2802 → Viread; Viread 300mg(Tenofovir disoproxil fumarate); DA-2802 319mg(Tenofovir disoproxil orotate)	Drug: Viread 300mg; single dose administration after 10hr fasting; Other Names: Tenofovir disoproxil fumarate; Drug: DA-2802 319mg; single dose administration after 10hr fasting; Other Names: Tenofovir disoproxil orotate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve(AUC)last of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Maximum of concentration(Cmax) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of maximum concentration(Tmax) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Terminal half-life(t1/2) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Apparent Clearance(CL/F) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Area Under Curve(AUC)inf of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Kyung-sang Yu, Ph.D, M.B.A, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2015
• Primary Completion (Actual): November 17, 2015
• Study Completion (Actual): March 8, 2016

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hepatitis B
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: DA2802_BE_I