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

NCT02557594 | Completed Phase 1 DMC

• 1 other identifier: DA2802_BE_I
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Hepatitis B

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Viread → DA-2802

EXPERIMENTAL

* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)

Drug: Viread 300mg; Drug: DA-2802 319mg

DA-2802 → Viread

EXPERIMENTAL

* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)

Drug: Viread 300mg; Drug: DA-2802 319mg

Interventions

Viread 300mg DRUG

single dose administration after 10hr fasting

Also known as: Tenofovir disoproxil fumarate

DA-2802 → Viread; Viread → DA-2802

DA-2802 319mg DRUG

single dose administration after 10hr fasting

Also known as: Tenofovir disoproxil orotate

DA-2802 → Viread; Viread → DA-2802

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyung-sang Yu, Ph.D, M.B.A

  Seoul National University Hospital

  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: September 22, 2015
• First Posted: September 23, 2015
• Study Start: October 6, 2015
• Primary Completion: November 17, 2015
• Study Completion: March 8, 2016
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

KR (1)