Chronic Hepatitis BPhase 1NCT02589457
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
A Phase 1 study testing CKD-390 and Viread® tablet in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men only
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- CKD-390 and Viread® tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 2015
- 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 19 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male volunteer in the age of 19-45
- Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
- Subject without a hereditary problems, chronic disease and morbid symptom
- Subject who sign on an informed consent form willingly
Who cannot join
- Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
- Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
- Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
- Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
- Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
Show all 16Show fewer
- Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
- The history of drug abuse or drug abuse showed a positive for urine drug test
- Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
- Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
- Taking drugs have received any other investigational drug within 3 months prior to the first dosing
- Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
- Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
- Cigarette > 10 cigarettes a day on average for recent 3 months
- Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Jung-gu, 301-721
About this study
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
Read the detailed description
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
- Conditions
- Chronic Hepatitis B
- Being tested
- CKD-390, Viread® tablet
- Keywords
- Chronic Hepatitis B virus, HIV-1 infection, Healthy Male Volunteer, Tenofovir Disoproxil Fumarate
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-390Drug
Tenofovir Disoproxil Aspartate 1T PO
Viread® tabletDrug
Tenofovir Disoproxil Fumarate 1T PO
| Study group | Role | What they receive |
|---|---|---|
| Viread® tablet | Active comparator | Tenofovir Disoproxil Fumarate Receives: Drug: Viread® tablet |
| CKD-390 | Experimental | Tenofovir Disoproxil Fumarate Receives: Drug: CKD-390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Tenofovir
Measured: 0(Pre-dose) up to 72hr
Secondary outcomes (9)
AUCinf
Measured: 0(Pre-dose) up to 72hr
Blood pressure
Measured: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
tmax
Measured: 0(Pre-dose) up to 72hr
t1/2β
Measured: 0(Pre-dose) up to 72hr
Clearance/F
Measured: 0(Pre-dose) up to 72hr
Electrocardiography
Measured: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Physical Examination
Measured: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Pulse rate
Measured: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Temperature
Measured: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang Hee Hong, MD, PhD, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589457
- Sponsor's protocol ID
- 163BE15028
- Status last verified
- Jan 2016
- First submitted
- 6 Oct 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02589457
- Acronym / sponsor ID
- 163BE15028
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B virus, HIV-1 infection, Healthy Male Volunteer, Tenofovir Disoproxil Fumarate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
Detailed description
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viread® tablet | Active comparator | Drug: Viread® tabletTenofovir Disoproxil Fumarate |
| CKD-390 | Experimental | Drug: CKD-390Tenofovir Disoproxil Fumarate |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteer in the age of 19-45
- Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
- Subject without a hereditary problems, chronic disease and morbid symptom
- Subject who sign on an informed consent form willingly
Key exclusion criteria (16 listed)
- Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
- Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
- Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
- Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-390Tenofovir Disoproxil Aspartate 1T PO | Drug | CKD-390 |
| Viread® tabletTenofovir Disoproxil Fumarate 1T PO | Drug | Viread® tablet |
Primary outcome
AUCt of Tenofovir
Time frame: 0(Pre-dose) up to 72hr
9 secondary outcomes
AUCinf
Time frame: 0(Pre-dose) up to 72hr
Blood pressure
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
tmax
Time frame: 0(Pre-dose) up to 72hr
t1/2β
Time frame: 0(Pre-dose) up to 72hr
Clearance/F
Time frame: 0(Pre-dose) up to 72hr
Electrocardiography
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Physical Examination
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Pulse rate
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Temperature
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jang Hee Hong, MD, PhD principal investigator
Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-390 and Viread® tablet in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 16 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 Jan 2016. 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?
AUCt of Tenofovir (time frame: 0(Pre-dose) up to 72hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2016.