Neuropathic PainPhase 1NCT03963362
The Pharmacokinetics of GLA5PR Tablet According to the Renal Function
A Phase 1 study testing GLA5PR tablet 75 mg and GLA5PR tablet 150 mg in people with Neuropathic Pain, run by GL Pharm Tech Corporation at 1 site in South Korea.
Trial summary
To evauate pharmacokinetics of GLA5PR tablet according to the renal function Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- GLA5PR tablet 75 mg and GLA5PR tablet 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Sep 2019to 30 Jun 2021
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject who, at the time of screening, are the age between 19 and 64 years
- Subject who has body weight more than 50 kg (45 kg in women), and less than 80 kg
- Subject who normal renal function of the creatinine clearance calculated by Cockcroft-Gault equation over 90 mL/min
- Subject who the mild renal function of the creatinine clearance between 60 and 89 mL/min calculated by Cockcroft-Gault equation
- Subject who the moderate renal patient of the creatinine clearance between 30 and 59 mL/min calculated by Cockcroft-Gault equation
- Subject who is clinically no significant by a medical history, physical, and psychological examination
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- Subject who clinically no significant a vital sign with Investigator's judgment
- Subject who has result of diagnostic laboratory test excluding the items described in exclusion criteria of the 13, and 14, and judged to be clinically no significant when medically by investigator
- Subject who has consented to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the first administration of the clinical trial drug to the end of the clinical trial (when testing for final safety evaluation) and not to provide sperm or egg
- Subject who is negative the serum and urine hCG test, and is not to pregnant and feeding
- Subject who signed and dated the informed consent form after understanding fully to hear a detailed explanation in the clinical trial
- Subject who is accept to the post-study visit and to be willing to providing of collection the blood, and urine
Who cannot join
- Subject who is any history of gastrointestinal disease (e.g., Crohn's disease, and others), and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- Subject who has a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs or other drugs (aspirin, antibiotics, etc.) that contain components of the clinical trial drug or components of the same class (except for inactive allergic rhinitis)
- Subject who is genetic problem such as galactose intolerance, or Lapp lactose dehydrogenase deficiency, or glucose-galactose uptake disorder
- Subject with the exclusion criteria of 1 to 3, or a significant disease (epilepsy, etc.) and past disease that is considered difficult to participate in clinical trials according to the investigator's judgement
- Subject who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 60 days before the first administration
- Subject who has participated in any other clinical trials and had medication within 180 days prior to the first administration of investigational product
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- Subject who has taken any ethical-the-counter drug or has taken any over-the-counter drug within 14 days before the screening visit, except to the taken the prior-medication for the disease treatment
- Subject who has taken any oriental medicines or any dietary supplements within 30 days, before the screening visit
- Subject who has taken any heavy drinking within 30 days before the screening visit (>21 units/week)
- Subject who has taken a food expected to have an effect on the clinical trial within 7 days, before the screening visit; The food of contained in caffeine (> 2 times/day) The products containing grapefruit (> 2 times/day)
- Subject who has shown positive reaction to drugs that may be abused from a urine drug screening
- Subject who is positive result in smoking or urine nicotine test within 30 days, before the screening visit
- Subject who is positive result in serum test (hepatitis type B test, hepatitis type C test, Human Immunodeficiency Virus (HIV) test, and syphilis test), during the screening period
- Subject who showed the following findings in the tests conducted during the screening period;
- Less than the lower normal limit (LNL) in the Hb.
- In excess of 1.5 times the upper normal limit (UNL) in the hepatic enzyme (AST and ALT), and the alkaline phosphatase values
- In excess of 1.5 times the upper normal limit (UNL) in the total bilirubin
- Subject who is QTc > 450 msec in ECG or a clinically significant abnormal rhythm during the screening period
- Subject who is not eligible person for the clinical trial according to the investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Hyeong-Seok Lim, MD, Ph D.
Hyeong-Seok Lim, MD, Ph D.
About this study
Official title: Clinical Study to Evaluate Pharmacokinetics of GLA5PR Tablet According to the Renal Function
To evauate pharmacokinetics of GLA5PR tablet according to the renal function
- Conditions
- Neuropathic Pain
- Being tested
- GLA5PR tablet 75 mg, GLA5PR tablet 150 mg
- Keywords
- GLA5PR, Renal function, Pharmacokinetics, Pregabalin
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA5PR tablet 75 mgDrug
GLARS-NF3 tablet
GLA5PR tablet 150 mgDrug
GLARS-NF3 tablet
| Study group | Role | What they receive |
|---|---|---|
| Administration of GLA5PR 75 mg as 60~89 mL/min | Experimental | Administration of GLA5PR 75 mg as 60~89 mL/min(CLcr) Receives: Drug: GLA5PR tablet 75 mg |
| Administration of GLA5PR 75 mg over 90 mL/min | Experimental | Administration of GLA5PR 75 mg over 90 mL/min(CLcr) Receives: Drug: GLA5PR tablet 75 mg |
| Administration of GLA5PR 150 mg as 60~89 mL/min | Experimental | Administration of GLA5PR 150 mg as 60~89 mL/min(CLcr) Receives: Drug: GLA5PR tablet 150 mg |
| Administration of GLA5PR 150 mg over 90 mL/min | Experimental | Administration of GLA5PR 150 mg over 90 mL/min(CLcr) Receives: Drug: GLA5PR tablet 150 mg |
| Administration of GLA5PR 75 mg as 30~59 mL/min | Experimental | Administration of GLA5PR 75 mg as 30~59 mL/min(CLcr) Receives: Drug: GLA5PR tablet 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cmax of Pregabalin
Cmax
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
The AUClast of Pregabalin
AUClast
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Secondary outcomes (5)
tmax of Pregabalin
tmax
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration
t1/2beta of Pregabalin
t1/2beta
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
AUCinf of Pregabalin
AUCinf
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
CL/F of Pregabalin
CL/F
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Vz/F of Pregabalin
Vz/F
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start17 Sep 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GL Pharm Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minchang Kwon, Ph. D, Study director, GL PharmTech Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963362
- Sponsor's protocol ID
- GLA5PR-107
- Status last verified
- Jul 2020
- First submitted
- 23 May 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Pharmacokinetics of GLA5PR Tablet According to the Renal Function
- ClinicalTrials.gov ID
- NCT03963362
- Acronym / sponsor ID
- GLA5PR-107
- Conditions
- Neuropathic Pain
- Keywords
- GLA5PR, Renal function, Pharmacokinetics, Pregabalin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- GL Pharm Tech CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 May 2019 (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 evauate pharmacokinetics of GLA5PR tablet according to the renal function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Administration of GLA5PR 75 mg as 60~89 mL/min | Experimental | Drug: GLA5PR tablet 75 mgAdministration of GLA5PR 75 mg as 60~89 mL/min(CLcr) |
| Administration of GLA5PR 75 mg over 90 mL/min | Experimental | Drug: GLA5PR tablet 75 mgAdministration of GLA5PR 75 mg over 90 mL/min(CLcr) |
| Administration of GLA5PR 150 mg as 60~89 mL/min | Experimental | Drug: GLA5PR tablet 150 mgAdministration of GLA5PR 150 mg as 60~89 mL/min(CLcr) |
| Administration of GLA5PR 150 mg over 90 mL/min | Experimental | Drug: GLA5PR tablet 150 mgAdministration of GLA5PR 150 mg over 90 mL/min(CLcr) |
| Administration of GLA5PR 75 mg as 30~59 mL/min | Experimental | Drug: GLA5PR tablet 75 mgAdministration of GLA5PR 75 mg as 30~59 mL/min(CLcr) |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy subject who, at the time of screening, are the age between 19 and 64 years
- Subject who has body weight more than 50 kg (45 kg in women), and less than 80 kg
- Subject who normal renal function of the creatinine clearance calculated by Cockcroft-Gault equation over 90 mL/min
- Subject who the mild renal function of the creatinine clearance between 60 and 89 mL/min calculated by Cockcroft-Gault equation
- Subject who the moderate renal patient of the creatinine clearance between 30 and 59 mL/min calculated by Cockcroft-Gault equation
Key exclusion criteria (19 listed)
- Subject who is any history of gastrointestinal disease (e.g., Crohn's disease, and others), and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- Subject who has a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs or other drugs (aspirin, antibiotics, etc.) that contain components of the clinical trial drug or components of the same class (except for inactive allergic rhinitis)
- Subject who is genetic problem such as galactose intolerance, or Lapp lactose dehydrogenase deficiency, or glucose-galactose uptake disorder
- Subject with the exclusion criteria of 1 to 3, or a significant disease (epilepsy, etc.) and past disease that is considered difficult to participate in clinical trials according to the investigator's judgement
- Subject who had whole blood donation within 60 days or component blood donation within 30 days before the first administration of the investigational product, or transfusion within 60 days before the first administration
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 |
|---|---|---|
| GLA5PR tablet 75 mgGLARS-NF3 tablet | Drug | Administration of GLA5PR 75 mg as 30~59 mL/min, Administration of GLA5PR 75 mg as 60~89 mL/min, Administration of GLA5PR 75 mg over 90 mL/min |
| GLA5PR tablet 150 mgGLARS-NF3 tablet | Drug | Administration of GLA5PR 150 mg as 60~89 mL/min, Administration of GLA5PR 150 mg over 90 mL/min |
Primary outcome
The Cmax of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Cmax
The AUClast of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
AUClast
5 secondary outcomes
tmax of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours after administration
t1/2beta of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
AUCinf of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
CL/F of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Vz/F of Pregabalin
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
Minchang Kwon, Ph. D study director
GL PharmTech Corp.
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 GLA5PR tablet 75 mg and GLA5PR tablet 150 mg in people with Neuropathic Pain, run by GL Pharm Tech Corporation 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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 23 Jul 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Hyuk Jung, MS (82-31-739-5220 ext. 404, jhjung@glpt.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cmax of Pregabalin (time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, and 72 hours after administration). 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 23 Jul 2020.