HealthyPhase 1NCT01842516
Multiple Ascending Dose Study for LCB01-0371
A Phase 1 study testing LCB01-0371 800mg and LCB01-0371 1200mg in people with Healthy, run by LigaChem Biosciences, Inc. at 1 site in South Korea.
Trial summary
Primary To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LCB01-0371 800mg and LCB01-0371 1200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
- Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- Able to donate blood during study period and follow visit.
- Agree to continue to use a reliable method of birth control until 60 days after study completion.
- Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- History of gastrointestinal problem which is affect to absorption within 6 months from screening
- History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
- History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics of LCB01-0371 in Healthy Male Subjects.
Primary
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
- To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
- To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects
Read the detailed description
- To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
- Conditions
- Healthy
- Being tested
- LCB01-0371 800mg, LCB01-0371 1200mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCB01-0371 800mgDrug
Also called LCB0-0371 800mg
LCB0-0371 800mg
LCB01-0371 1200mgDrug
LCB01-0371 1200mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LCB01-0371 800mg | Experimental | LCB01-0371 800mg Receives: Drug: LCB01-0371 800mg |
| LCB01-0371 1200mg | Experimental | LCB01-0371 1200mg Receives: Drug: LCB01-0371 1200mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 7 days
Secondary outcomes (2)
Area under the plasma concentration versus time curve (AUC) of LCB01-0371
Measured: Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionDec 2013
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 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, MD, PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842516
- Sponsor's protocol ID
- LCB01-0371-12-1-02
- Status last verified
- Nov 2014
- First submitted
- 20 Apr 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.
PubMed 30420289
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics of LCB01-0371 in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT01842516
- Acronym / sponsor ID
- LCB01-0371-12-1-02
- 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
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Apr 2013 (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.
Primary
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
- To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
- To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects
Detailed description
- To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
- To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LCB01-0371 800mg | Experimental | Drug: LCB01-0371 800mgLCB01-0371 800mg |
| LCB01-0371 1200mg | Experimental | Drug: LCB01-0371 1200mgLCB01-0371 1200mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
- Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- Able to donate blood during study period and follow visit.
- Agree to continue to use a reliable method of birth control until 60 days after study completion.
- Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Key exclusion criteria (4 listed)
- History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- History of gastrointestinal problem which is affect to absorption within 6 months from screening
- History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
- History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
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 800mgAlso: LCB0-0371 800mgLCB0-0371 800mg | Drug | LCB01-0371 800mg |
| LCB01-0371 1200mgLCB01-0371 1200mg | Drug | LCB01-0371 1200mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to 7 days
2 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of LCB01-0371
Time frame: Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371
Time frame: Up to 7 days
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 17 Nov 2014.
- Derived from this study: PubMed 30420289Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.
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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.
Kyun-Seop Bae, MD, PhD. principal investigator
Asan 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 LCB01-0371 800mg and LCB01-0371 1200mg 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 4 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 17 Nov 2014. 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. Some participants in this study may receive a placebo. 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 participants with adverse events (time frame: Up to 7 days). 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 NCT01842516, 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 17 Nov 2014.