Chronic Hepatitis BPhase 1NCT02300688
Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
A Phase 1 study testing Treatment A and Treatment B in people with Chronic Hepatitis B, run by IlDong Pharmaceutical Co Ltd.
Trial summary
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Treatment A and Treatment B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Feb 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male whose age is 19 years or more and 55 years or less in full at the time of screening test
- Subjects whose body mass index is 19 kg/m2 or more and 27 kg/m2 or less at the time of screening test
- Subjects who listened to sufficient explanation of the purpose and contents of the Clinical Trial and characteristics of the test drug and spontaneously agreed to participate in the study in writing
- Subjects who have ability and volition to participate in the Clinical Trial in the entire period of it
Who cannot join
- Subjects who have clinically significant diseases or medical history of the diseases such as hepatobiliary, gastrointestinal, urinary, respiratory, cardiovascular system, musculoskeletal, endocrine system, neuropsychiatric disease, blood disease and tumor
- Subjects who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Subjects who have medical history of hypersensitivity to the drugs (aspirin, antibiotics) or have allergic diseases that require treatment
- Subjects who were administered to investigational product within the past 60 days from the day of random allocation
- Subjects who donated whole blood within the past 60 days from the day of random allocation or donated component blood within the past 30 days from the day of random allocation
- Subjects who took the drug which needs doctor's prescription or oriental herbal medicine within the past 14 days from the day of random allocation or took over-the-counter drug within the past 7 days from the day of random allocation (Only, can be selected as subject according to decision of the investigator)
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- Subjects whose average drinking quantity per week exceeds alcohol 140g
- Subjects whose average smoking quantity exceeds 20 cigarettes or subjects who cannot stop smoking during their hospitalization
- Subjects whose average quantity of intake of grapefruit juice per day exceeds 4 glasses
- Subjects whose systolic blood pressure is less than 90 mmHg or more than 140 mmHg or diastolic pressure is less than 60 mmHg or more than 100 mmHg at the time of screening test
- Subjects whose AST, ALT, total bilirubin, γ-glutamyl transferasevalues in blood exceed 1.5 times of the upper limit of reference
- Subjects whose Creatine phosphokinase value in blood exceeds 2.5 times of the upper limit of reference
- Subjects whose glomerular filtration rate calculated from creatinine value in blood is less than 60 mL/min.
- Subjects who do not show negative reaction in tests for hepatitis B, tests for hepatitis C, HIV test and tests for syphilis
- Subjects who show positive reaction in urine drug screening test
- Subjects who were decided to be not suitable for participation in the Clinical Trial by investigators for other reasons
About this study
Official title: An Open Label, Randomized, 2-sequence, 2-period, Single-dose Cross-over Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.
Read the detailed description
The purpose of this study is to evaluate equivalence of bioavailability of LB80331 preparations different. Following the randomly allocated sequence group administer the relevant test drug for 1 time according to the determined schedule of Treatment A and Treatment B in each of the periods.
- Conditions
- Chronic Hepatitis B
- Being tested
- Treatment A, Treatment B
- 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.
Treatment ADrug
Also called LB80380 maleate made by IDP
administration of 1 time administration of the test drug (Treatment A)
Treatment BDrug
Also called LB80380 maleate made by LGLS
administration of 1 time administration of the reference drug (Treatment B)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Period 1 (Treatment A) - Wash out - Period 2 (Treatment B) Receives: Drug: Treatment A; Drug: Treatment B |
| Arm 2 | Experimental | Period 1 (Treatment B) - Wash out - Period 2 (Treatment A) Receives: Drug: Treatment A; Drug: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
Cmax
Measured: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
Secondary outcomes (3)
tmax
Measured: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
t1/2
Measured: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
AUCinf
Measured: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionFeb 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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeong-Ryeol Kim, Ph D., Principal investigator, Samsung Medical Center, Professor of department of clinical pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300688
- Sponsor's protocol ID
- ID_BVCL013
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, 2-sequence, 2-period, Single-dose Cross-over Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02300688
- Acronym / sponsor ID
- ID_BVCL013
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Nov 2014 (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.
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.
Detailed description
The purpose of this study is to evaluate equivalence of bioavailability of LB80331 preparations different. Following the randomly allocated sequence group administer the relevant test drug for 1 time according to the determined schedule of Treatment A and Treatment B in each of the periods.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Treatment A, Drug: Treatment BPeriod 1 (Treatment A) - Wash out - Period 2 (Treatment B) |
| Arm 2 | Experimental | Drug: Treatment A, Drug: Treatment BPeriod 1 (Treatment B) - Wash out - Period 2 (Treatment A) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male whose age is 19 years or more and 55 years or less in full at the time of screening test
- Subjects whose body mass index is 19 kg/m2 or more and 27 kg/m2 or less at the time of screening test
- Subjects who listened to sufficient explanation of the purpose and contents of the Clinical Trial and characteristics of the test drug and spontaneously agreed to participate in the study in writing
- Subjects who have ability and volition to participate in the Clinical Trial in the entire period of it
Key exclusion criteria (16 listed)
- Subjects who have clinically significant diseases or medical history of the diseases such as hepatobiliary, gastrointestinal, urinary, respiratory, cardiovascular system, musculoskeletal, endocrine system, neuropsychiatric disease, blood disease and tumor
- Subjects who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Subjects who have medical history of hypersensitivity to the drugs (aspirin, antibiotics) or have allergic diseases that require treatment
- Subjects who were administered to investigational product within the past 60 days from the day of random allocation
- Subjects who donated whole blood within the past 60 days from the day of random allocation or donated component blood within the past 30 days from the day of random allocation
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 |
|---|---|---|
| Treatment AAlso: LB80380 maleate made by IDPadministration of 1 time administration of the test drug (Treatment A) | Drug | Arm 1, Arm 2 |
| Treatment BAlso: LB80380 maleate made by LGLSadministration of 1 time administration of the reference drug (Treatment B) | Drug | Arm 1, Arm 2 |
Primary outcome
AUClast
Time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
Cmax
Time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
3 secondary outcomes
tmax
Time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
t1/2
Time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
AUCinf
Time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
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 13 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.
Jeong-Ryeol Kim, Ph D. principal investigator
Samsung Medical Center, Professor of department of clinical pharmacology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A and Treatment B in people with Chronic Hepatitis B, run by IlDong Pharmaceutical Co Ltd.
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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
AUClast (time frame: preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours 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?
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 13 Jan 2016.