Ulcerative ColitisPhase 1NCT04360343
Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
A Phase 1 study testing Film-coated tablet in people with Ulcerative Colitis, run by LG Chem at 1 site in South Korea.
Trial summary
To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Film-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2020to 1 Dec 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between the age of 19 and 45 at the screening visit
- Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
- Subjects who were confirmed to be healthy based on the medical history
- Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent
Who cannot join
- Subjects with a clinically significant disease or history in liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system or cardiovascular system
- Subjects with a disease (e.g., Crohn's disease, etc.) or history of surgery (except for simple appendectomy and herniotomy) in gastrointestinal system which may affect the absorption of the investigational product
- Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
- Subjects who had donated whole blood within 2 months, component blood within 1 month, or received transfusion within 1 month prior to the first administration day
- Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
- Subjects who had eaten grapefruit/caffeine-containing food within 3 days prior to the first hospitalization or subjects who could not stop taking food containing grapefruit or caffeine from 3 days prior to hospitalization to the discharge day
Show all 12Show fewer
- Subjects who had taken any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator's discretion)
- Subjects who taking excessive caffeine or alcohol or heavy smoker (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL as pure alcohol), smoking > 10 cigarettes/day)
- Subjects who had a history of tuberculosis (TB) infection or a positive result in the Quantiferon TB-Gold test and the chest X-ray in the screening tests
- Subjects who unable to take the food provided by the study institution
- Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test)
- Other cases that the investigator consider unsuitable as the subject
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University College of Medicine and Hospital
Seoul
About this study
Official title: A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.
- Conditions
- Ulcerative Colitis
- Being tested
- Film-coated tablet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Film-coated tabletDrug
uncoated tablet
| Study group | Role | What they receive |
|---|---|---|
| LC51-0255 film-coated tablet | Experimental | Drug: LC51-0255 Receives: Drug: Film-coated tablet |
| LC51-0255 uncoated tablet | Active comparator | Drug: LC51-0255 Receives: Drug: Film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Outcome Measures
Peak Plasma Concentration (Cmax)
Measured: baseline,during the procedure
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Measured: baseline,during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360343
- Sponsor's protocol ID
- LG-SGCL003
- Status last verified
- Jan 2021
- First submitted
- 6 Apr 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04360343
- Acronym / sponsor ID
- LG-SGCL003
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Apr 2020 (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 compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC51-0255 film-coated tablet | Experimental | Drug: Film-coated tabletDrug: LC51-0255 |
| LC51-0255 uncoated tablet | Active comparator | Drug: Film-coated tabletDrug: LC51-0255 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females between the age of 19 and 45 at the screening visit
- Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
- Subjects who were confirmed to be healthy based on the medical history
- Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent
Key exclusion criteria (12 listed)
- Subjects with a clinically significant disease or history in liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system or cardiovascular system
- Subjects with a disease (e.g., Crohn's disease, etc.) or history of surgery (except for simple appendectomy and herniotomy) in gastrointestinal system which may affect the absorption of the investigational product
- Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
- Subjects who had donated whole blood within 2 months, component blood within 1 month, or received transfusion within 1 month prior to the first administration day
- Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
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 |
|---|---|---|
| Film-coated tabletuncoated tablet | Drug | LC51-0255 film-coated tablet, LC51-0255 uncoated tablet |
Primary outcome
Pharmacokinetic Outcome Measures
Time frame: baseline,during the procedure
Peak Plasma Concentration (Cmax)
Pharmacokinetic Outcome Measures
Time frame: baseline,during the procedure
Area under the plasma concentration versus time curve (AUC)
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 22 Jan 2021.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Film-coated tablet in people with Ulcerative Colitis, 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 4 inclusion and 12 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 22 Jan 2021. 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?
Pharmacokinetic Outcome Measures (time frame: baseline,during the procedure). 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 22 Jan 2021.