HealthyPhase 1NCT03492996
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
A Phase 1 study testing LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose in people with Healthy, run by LigaChem Biosciences, Inc. at 1 site in South Korea.
Trial summary
The primary objectives of the study are: To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2020to 23 Sep 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 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged 19 to 45 (inclusive) years
- Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
- Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
- Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
- Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc
Who cannot join
- Subjects who had a clinically significant disease or a past history of disease
- Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.
- Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) > 2.5 times upper limit of normal
- Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
- Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mass Balance Study to Investigate the Absorption, Metabolism, Excretion of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371- Microtracer Dose in Healthy Male Subjects
The primary objectives of the study are:
- To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
Read the detailed description
This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.
- Conditions
- Healthy
- Being tested
- LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCB01-0371 dose with a [14C]-LCB01-0371-tracer doseDrug
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| LCB01-0371 dose with a [14C]-LCB01-0371-tracer | Experimental | A mass balance study to investigate the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose in healthy male subjects Receives: Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the AME of LCB01-0371
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects.
Blood, urine, feces, and expired air samples will be collected according to the following schedules
- Blood: Plasma(20 points), Whole blood(2 points)
- Urine : 11 points
- Feces : 8 points
- Expired air: 14points
Measured: an average of 8 days (+ - 1 D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start21 Jun 2020
- Primary completion3 Aug 2020
- Study completion23 Sep 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492996
- Sponsor's protocol ID
- LCB01-0371-17-1-06
- Status last verified
- Nov 2020
- First submitted
- 1 Apr 2018
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study to Investigate the Absorption, Metabolism, Excretion of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371- Microtracer Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03492996
- Acronym / sponsor ID
- LCB01-0371-17-1-06
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 10 Apr 2018 (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.
The primary objectives of the study are:
- To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
Detailed description
This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCB01-0371 dose with a [14C]-LCB01-0371-tracer | Experimental | Drug: LCB01-0371 dose with a [14C]-LCB01-0371-tracer doseA mass balance study to investigate the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose in healthy male subjects |
Who may qualify
- Ages
- 19 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male adults aged 19 to 45 (inclusive) years
- Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
- Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
- Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
- Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc
Key exclusion criteria (5 listed)
- Subjects who had a clinically significant disease or a past history of disease
- Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.
- Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) > 2.5 times upper limit of normal
- Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
- Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), 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 dose with a [14C]-LCB01-0371-tracer doseTo assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects | Drug | LCB01-0371 dose with a [14C]-LCB01-0371-tracer |
Primary outcome
Assess the AME of LCB01-0371
Time frame: an average of 8 days (+ - 1 D)
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects. Blood, urine, feces, and expired air samples will be collected according to the following schedules 1. Blood: Plasma(20 points), Whole blood(2 points) 2. Urine : 11 points 3. Feces : 8 points 4. Expired air: 14points
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 12 Mar 2021.
- 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.
Howard Lee principal investigator
Seoul National University 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 dose with a [14C]-LCB01-0371-tracer dose 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 5 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 12 Mar 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?
Assess the AME of LCB01-0371 (time frame: an average of 8 days (+ - 1 D)). 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 12 Mar 2021.