HealthyPhase 1NCT02538003
To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
A Phase 1 study testing LCB01-0371 Tablet 800 mg(R) and LCB01-0371 Tablet 800 mg(T) in people with Healthy, run by LigaChem Biosciences, Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LCB01-0371 Tablet 800 mg(R) and LCB01-0371 Tablet 800 mg(T)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
- Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
- Capable of performing follow up visit, blood sampling
- Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
- Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
Who cannot join
- History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
- History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
- History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics(except non active allergic rhinitis)
- History of drug abuse or positive result at urine drug screening test at screening visit
- Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
- Other: Patients considered unable perform for the study by the investigator concerning
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects
The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.
Read the detailed description
A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- LCB01-0371 Tablet 800 mg(R), LCB01-0371 Tablet 800 mg(T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCB01-0371 Tablet 800 mg(R)Drug
Also called LCB01-0371 Tablet 400 mg 2 Tablet
Reference: taken drug before meal
LCB01-0371 Tablet 800 mg(T)Drug
Also called LCB01-0371 Tablet 400 mg 2 Tablet
Test: taken drug after meal
| Study group | Role | What they receive |
|---|---|---|
| Group 1(RT):LCB01-0371 Tablet 800mg | Experimental | 1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal)
2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal) Receives: Drug: LCB01-0371 Tablet 800 mg(R); Drug: LCB01-0371 Tablet 800 mg(T) |
| Group 2(TR):LCB01-0371 Tablet 800mg | Experimental | 1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal)
2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal) Receives: Drug: LCB01-0371 Tablet 800 mg(R); Drug: LCB01-0371 Tablet 800 mg(T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events
Measured: From date of randomization until follow up after 7 days from last hospital discharge
Secondary outcomes (2)
Pharmacokinetics: AUClast(Area under the plasma concentration)
Measured: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Pharmacokinetics: Cmax(Peak plasma concentration)
Measured: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 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 HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaeyong Chung, M.D., Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538003
- Sponsor's protocol ID
- LCB01-0371-13-1-03
- Status last verified
- Mar 2016
- First submitted
- 27 Aug 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02538003
- Acronym / sponsor ID
- LCB01-0371-13-1-03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Sep 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 assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.
Detailed description
A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(RT):LCB01-0371 Tablet 800mg | Experimental | Drug: LCB01-0371 Tablet 800 mg(R), Drug: LCB01-0371 Tablet 800 mg(T)1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal) 2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal) |
| Group 2(TR):LCB01-0371 Tablet 800mg | Experimental | Drug: LCB01-0371 Tablet 800 mg(R), Drug: LCB01-0371 Tablet 800 mg(T)1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal) 2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
- Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
- Capable of performing follow up visit, blood sampling
- Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
- Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
Key exclusion criteria (6 listed)
- History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
- History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
- History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics(except non active allergic rhinitis)
- History of drug abuse or positive result at urine drug screening test at screening visit
- Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
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 |
|---|---|---|
| LCB01-0371 Tablet 800 mg(R)Also: LCB01-0371 Tablet 400 mg 2 TabletReference: taken drug before meal | Drug | Group 1(RT):LCB01-0371 Tablet 800mg, Group 2(TR):LCB01-0371 Tablet 800mg |
| LCB01-0371 Tablet 800 mg(T)Also: LCB01-0371 Tablet 400 mg 2 TabletTest: taken drug after meal | Drug | Group 1(RT):LCB01-0371 Tablet 800mg, Group 2(TR):LCB01-0371 Tablet 800mg |
Primary outcome
Number of Adverse events
Time frame: From date of randomization until follow up after 7 days from last hospital discharge
2 secondary outcomes
Pharmacokinetics: AUClast(Area under the plasma concentration)
Time frame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Pharmacokinetics: Cmax(Peak plasma concentration)
Time frame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
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 23 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Jaeyong Chung, M.D., Ph.D principal investigator
Seoul National University Bundang 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 LCB01-0371 Tablet 800 mg(R) and LCB01-0371 Tablet 800 mg(T) in people with Healthy, run by LigaChem Biosciences, Inc. 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 6 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 23 Mar 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?
Number of Adverse events (time frame: From date of randomization until follow up after 7 days from last hospital discharge). 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 23 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.