Clinical trial NCT02557594: Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Hepatitis B
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under Curve(AUC)last of Tenofovir
timeFrame: 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
measure: Maximum of concentration(Cmax) of Tenofovir
timeFrame: 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:
measure: Time of maximum concentration(Tmax) of Tenofovir
timeFrame: 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
measure: Terminal half-life(t1/2) of Tenofovir
timeFrame: 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
measure: Apparent Clearance(CL/F) of Tenofovir
timeFrame: 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
measure: Area Under Curve(AUC)inf of Tenofovir
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-sang Yu, Ph.D, M.B.A
role: PRINCIPAL_INVESTIGATOR
References: