HyperuricemiaPhase 1NCT01361646
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
A Phase 1 study testing LC350189 in people with Hyperuricemia and Gout, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- LC350189
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Jan 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 20 and 50 years at screening
- Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2.
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
- Conditions
- Hyperuricemia, Gout
- Being tested
- LC350189
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC350189Drug
Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
| Study group | Role | What they receive |
|---|---|---|
| LC350189 | Experimental | Not described Receives: Drug: LC350189 |
| Febuxostat | Active comparator | Not described Receives: Drug: LC350189 |
| Placebo | Placebo comparator | Not described Receives: Drug: LC350189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of LC350189
Measured: 7 days(plus or minus 1 day)
Secondary outcomes (3)
Cmax
Measured: 3 days
AUC
Measured: 3days
Tmax
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361646
- Sponsor's protocol ID
- LG-GDCL001
- Status last verified
- Jun 2013
- First submitted
- 19 May 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
- ClinicalTrials.gov ID
- NCT01361646
- Acronym / sponsor ID
- LG-GDCL001
- Conditions
- Hyperuricemia, Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 May 2011 (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.
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LC350189 | Experimental | Drug: LC350189 |
| Febuxostat | Active comparator | Drug: LC350189 |
| Placebo | Placebo comparator | Drug: LC350189 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 20 and 50 years at screening
- Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2.
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LC350189Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg | Drug | Febuxostat, LC350189, Placebo |
Primary outcome
Adverse events of LC350189
Time frame: 7 days(plus or minus 1 day)
3 secondary outcomes
Cmax
Time frame: 3 days
AUC
Time frame: 3days
Tmax
Time frame: 3days
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 11 Jun 2013.
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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, PhD 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 LC350189 in people with Hyperuricemia and Gout, run by LG Life Sciences 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 0 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 11 Jun 2013. 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?
Adverse events of LC350189 (time frame: 7 days(plus or minus 1 day)). 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 11 Jun 2013.