HealthyPhase 1NCT03174613
A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255
A Phase 1 study testing LC51-0255 in people with Healthy, run by LG Chem at 1 site in South Korea.
Trial summary
1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects 2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects 3. To evaluate bioavailability of LC51-0255 Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LC51-0255
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2017to 11 Jul 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 19~45 years at screening.
- Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)
Who cannot join
- History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
- Exclusions Related to Laboratory Results: Platelet count < 100,000/μL, Hgb < 8.5 g/dL, Neutrophils < 1.5 /μL, Absolute WBC count < 3500/μL, Absolute lymphocyte count < 800/μL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255
- To evaluate the safety and tolerability of LC51-0255 in healthy male subjects
- To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects
- To evaluate bioavailability of LC51-0255
Read the detailed description
For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.
- Conditions
- Healthy
- Being tested
- LC51-0255, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC51-0255Drug
0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
PlaceboDrug
0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
| Study group | Role | What they receive |
|---|---|---|
| LC51-0255 | Experimental | tablets, PO Receives: Drug: LC51-0255 |
| Placebo | Placebo comparator | tablets, PO Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD determination
Safety and Tolerability
Measured: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study
Secondary outcomes (2)
Pharmacokinetic: Peak Plasma Concentration (Cmax)
Cmax
Measured: Cmax:168 hours post dose
Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)
AUC
Measured: AUCinf:168 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 posted2 Jun 2017
- Study start31 May 2017
- Primary completion12 Jun 2019
- Study completion11 Jul 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD,M.B.A., Principal investigator, Seoul National University Hospital, Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174613
- Sponsor's protocol ID
- LG-SGCL001
- Status last verified
- Sep 2020
- First submitted
- 25 May 2017
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255
- ClinicalTrials.gov ID
- NCT03174613
- Acronym / sponsor ID
- LG-SGCL001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- 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.
- To evaluate the safety and tolerability of LC51-0255 in healthy male subjects
- To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects
- To evaluate bioavailability of LC51-0255
Detailed description
For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC51-0255 | Experimental | Drug: LC51-0255tablets, PO |
| Placebo | Placebo comparator | Drug: Placebotablets, PO |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 19~45 years at screening.
- Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)
Key exclusion criteria (2 listed)
- History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
- Exclusions Related to Laboratory Results: Platelet count < 100,000/μL, Hgb < 8.5 g/dL, Neutrophils < 1.5 /μL, Absolute WBC count < 3500/μL, Absolute lymphocyte count < 800/μL
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 |
|---|---|---|
| LC51-02550.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg | Drug | LC51-0255 |
| Placebo0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg | Drug | Placebo |
Primary outcome
MTD determination
Time frame: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study
Safety and Tolerability
2 secondary outcomes
Pharmacokinetic: Peak Plasma Concentration (Cmax)
Time frame: Cmax:168 hours post dose
Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)
Time frame: AUCinf:168 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 18 Sep 2020.
- 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.
Kyung-Sang Yu, MD,M.B.A. principal investigator
Seoul National University Hospital, Clinical Trial 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 LC51-0255 in people with Healthy, run by LG Chem 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 2 inclusion and 2 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 18 Sep 2020. 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?
MTD determination (time frame: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study). 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 18 Sep 2020.