HealthyPhase 1NCT02882789
IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers
A Phase 1 study testing LCB01-0371 and LCB01-0371 400mg in people with Healthy, run by LigaChem Biosciences, Inc. at 1 site in South Korea.
Trial summary
Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose Read more about this study
- Who is it for?
- Ages 19 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LCB01-0371 and LCB01-0371 400mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Jul 2017
- 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male between 19 and 39 years of age at the time of screening
- Subjects with body mass index (BMI) between 19 and 27 at the time of screening
- Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
- 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 gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
- History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers
Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary
- To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose
- Conditions
- Healthy
- Being tested
- LCB01-0371, LCB01-0371 400mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCB01-0371Drug
Also called LCB01-0371 or placebo
Cohort1 \& 3: Placebo-controlled, Single ascending dose administration
LCB01-0371 400mgDrug
Also called LCB01-0371 400mg 2 tablet
Cohort 2: Crossover designed administration
| Study group | Role | What they receive |
|---|---|---|
| LCB01-0371 200mg | Experimental | LCB01-0371 IV 200 mg Receives: Drug: LCB01-0371 |
| LCB01-0371 400mg | Experimental | LCB01-0371 IV 400 mg Receives: Drug: LCB01-0371; Drug: LCB01-0371 400mg |
| LCB01-0371 800mg | Experimental | LCB01-0371 IV 800 mg Receives: Drug: LCB01-0371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess Peak Plasma Concentration(Cmax) of LCB01-0371
Measured: through study completion per patient, 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 posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionJul 2017
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LigaChem Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882789
- Sponsor's protocol ID
- LCB01-0371-16-1-01
- Status last verified
- Mar 2017
- First submitted
- 9 Aug 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15.
PubMed 30559004
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02882789
- Acronym / sponsor ID
- LCB01-0371-16-1-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LigaChem Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Aug 2016 (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 Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary
- To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LCB01-0371 200mg | Experimental | Drug: LCB01-0371LCB01-0371 IV 200 mg |
| LCB01-0371 400mg | Experimental | Drug: LCB01-0371, Drug: LCB01-0371 400mgLCB01-0371 IV 400 mg |
| LCB01-0371 800mg | Experimental | Drug: LCB01-0371LCB01-0371 IV 800 mg |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Male between 19 and 39 years of age at the time of screening
- Subjects with body mass index (BMI) between 19 and 27 at the time of screening
- Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
- Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
Key exclusion criteria (2 listed)
- History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
- History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture 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 |
|---|---|---|
| LCB01-0371Also: LCB01-0371 or placeboCohort1 \& 3: Placebo-controlled, Single ascending dose administration | Drug | LCB01-0371 200mg, LCB01-0371 400mg, LCB01-0371 800mg |
| LCB01-0371 400mgAlso: LCB01-0371 400mg 2 tabletCohort 2: Crossover designed administration | Drug | LCB01-0371 400mg |
Primary outcome
To assess Peak Plasma Concentration(Cmax) of LCB01-0371
Time frame: through study completion per patient, an average of 8 days (+ - 1 D)
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 10 Apr 2018.
- Derived from this study: PubMed 30559004Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15.
- Individual participant dataSharing planned: Undecided
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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.
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 LCB01-0371 and LCB01-0371 400mg 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 4 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 10 Apr 2018. 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?
To assess Peak Plasma Concentration(Cmax) of LCB01-0371 (time frame: through study completion per patient, 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?
On the ClinicalTrials.gov record for NCT02882789, 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 10 Apr 2018.