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HealthyPhase 1NCT02557594

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

A Phase 1 study testing Viread 300mg and DA-2802 319mg in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Viread 300mg and DA-2802 319mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
6 Oct 2015to 8 Mar 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Clinical Trial Center, Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

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

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
Being tested
Viread 300mg, DA-2802 319mg
Keywords
Hepatitis B
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viread 300mgDrug

    Also called Tenofovir disoproxil fumarate

    single dose administration after 10hr fasting

  • DA-2802 319mgDrug

    Also called Tenofovir disoproxil orotate

    single dose administration after 10hr fasting

Study groups in NCT02557594
Study groupRoleWhat they receive
Viread → DA-2802Experimental* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)
Receives: Drug: Viread 300mg; Drug: DA-2802 319mg
DA-2802 → VireadExperimental* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)
Receives: Drug: Viread 300mg; Drug: DA-2802 319mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under Curve(AUC)last of Tenofovir

    Measured: 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

  2. Maximum of concentration(Cmax) of Tenofovir

    Measured: 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)

  1. Time of maximum concentration(Tmax) of Tenofovir

    Measured: 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

  2. Terminal half-life(t1/2) of Tenofovir

    Measured: 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

  3. Apparent Clearance(CL/F) of Tenofovir

    Measured: 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

  4. Area Under Curve(AUC)inf of Tenofovir

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study start6 Oct 2015
  3. Primary completion17 Nov 2015
  4. Study completion8 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557594
Sponsor's protocol ID
DA2802_BE_I
Status last verified
Apr 2017
First submitted
22 Sep 2015
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Viread 300mg and DA-2802 319mg in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Curve(AUC)last of Tenofovir (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.

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