Hepatitis BPhase 1NCT01427868
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
A Phase 1 study testing LB80380 maleate salt and LB80380 free base in people with Hepatitis B, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- LB80380 maleate salt and LB80380 free base
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Dec 2010
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male with good health
- 20 to 45 years of age at screening
- Body weight ±20% of ideal body weight
- Willingness and ability to comply with study procedures and communicate with investigators
- Provided written consent voluntarily after informed of all the pertinent aspects of the trial
Who cannot join
- Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
- Clinically significant acute or chronic medical conditions
- Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
- Participation in clinical trial within 3 months before the first day of drug administration
- Alcohol abuse
- Habitual smoker
Show all 9Show fewer
- Habitual user of herbal medicine
- Use of grapefruit-containing food or grapefruit juice during the study period
- Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I Study in Healthy Male Subjects to Compare the Pharmacokinetics of LB80331 and LB80317, Metabolites of LB80380, After a Single Oral Administration of LB80380 Free Base 150 mg (60 mg + 90 mg) Tablet or LB80380 Maleate Tablet 183 mg (150 mg as a Free Base)
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
- Conditions
- Hepatitis B
- Being tested
- LB80380 maleate salt, LB80380 free base
- Keywords
- LB80380, bioequivalence
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB80380 maleate saltDrug
183 mg (150 mg as a free base)
LB80380 free baseDrug
150 mg
| Study group | Role | What they receive |
|---|---|---|
| LB80380 maleat salt | Experimental | Not described Receives: Drug: LB80380 maleate salt |
| LB80380 free base | Active comparator | Not described Receives: Drug: LB80380 free base |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: up to 144 hours
Cmax
Measured: up to 144 hours
Secondary outcomes (2)
Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability
Measured: up to 7 days
Profile of Pharmacokinetics
Tmax, Aet, CL/F
Measured: up to 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wooseong Huh, Prof, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427868
- Sponsor's protocol ID
- LG-BVCL009
- Status last verified
- Sep 2011
- First submitted
- 25 Aug 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716.
PubMed 22981147
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study in Healthy Male Subjects to Compare the Pharmacokinetics of LB80331 and LB80317, Metabolites of LB80380, After a Single Oral Administration of LB80380 Free Base 150 mg (60 mg + 90 mg) Tablet or LB80380 Maleate Tablet 183 mg (150 mg as a Free Base)
- ClinicalTrials.gov ID
- NCT01427868
- Acronym / sponsor ID
- LG-BVCL009
- Conditions
- Hepatitis B
- Keywords
- LB80380, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Sep 2011 (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 study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB80380 maleat salt | Experimental | Drug: LB80380 maleate salt |
| LB80380 free base | Active comparator | Drug: LB80380 free base |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male with good health
- 20 to 45 years of age at screening
- Body weight ±20% of ideal body weight
- Willingness and ability to comply with study procedures and communicate with investigators
- Provided written consent voluntarily after informed of all the pertinent aspects of the trial
Key exclusion criteria (9 listed)
- Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
- Clinically significant acute or chronic medical conditions
- Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
- Participation in clinical trial within 3 months before the first day of drug administration
- Alcohol abuse
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 |
|---|---|---|
| LB80380 maleate salt183 mg (150 mg as a free base) | Drug | LB80380 maleat salt |
| LB80380 free base150 mg | Drug | LB80380 free base |
Primary outcome
AUC
Time frame: up to 144 hours
Cmax
Time frame: up to 144 hours
2 secondary outcomes
Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability
Time frame: up to 7 days
Profile of Pharmacokinetics
Time frame: up to 144 hours
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 2 Sep 2011.
- Derived from this study: PubMed 22981147Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Wooseong Huh, Prof principal investigator
Samsung Medical Center
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 LB80380 maleate salt and LB80380 free base in people with Hepatitis B, run by LG Life Sciences 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 5 inclusion and 9 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 2 Sep 2011. 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?
AUC (time frame: up to 144 hours). 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 NCT01427868, which also lists 1 linked publication.
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 2 Sep 2011.