The Pharmacokinetics of GLA5PR Tablet According to the Renal Function

NCT ID: NCT03963362

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2021-06-30

Brief Summary

To evauate pharmacokinetics of GLA5PR tablet according to the renal function

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of GLA5PR 75 mg as 60~89 mL/min

Administration of GLA5PR 75 mg as 60\~89 mL/min(CLcr)

Group Type: EXPERIMENTAL

GLA5PR tablet 75 mg

Intervention Type: DRUG

GLARS-NF3 tablet

Administration of GLA5PR 75 mg over 90 mL/min

Administration of GLA5PR 75 mg over 90 mL/min(CLcr)

Group Type: EXPERIMENTAL

GLA5PR tablet 75 mg

Intervention Type: DRUG

GLARS-NF3 tablet

Administration of GLA5PR 150 mg as 60~89 mL/min

Administration of GLA5PR 150 mg as 60\~89 mL/min(CLcr)

Group Type: EXPERIMENTAL

GLA5PR tablet 150 mg

Intervention Type: DRUG

GLARS-NF3 tablet

Administration of GLA5PR 150 mg over 90 mL/min

Administration of GLA5PR 150 mg over 90 mL/min(CLcr)

Group Type: EXPERIMENTAL

GLA5PR tablet 150 mg

Intervention Type: DRUG

GLARS-NF3 tablet

Administration of GLA5PR 75 mg as 30~59 mL/min

Administration of GLA5PR 75 mg as 30\~59 mL/min(CLcr)

Group Type: EXPERIMENTAL

GLA5PR tablet 75 mg

Intervention Type: DRUG

GLARS-NF3 tablet

Interventions

GLA5PR tablet 75 mg

GLARS-NF3 tablet

Intervention Type: DRUG

GLA5PR tablet 150 mg

GLARS-NF3 tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Subject who clinically no significant a vital sign with Investigator's judgment

Exclusion Criteria

• 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

• 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 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
• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GL Pharm Tech Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minchang Kwon, Ph. D

Role: STUDY_DIRECTOR

GL PharmTech Corp.

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jong Hyuk Jung, MS

Role: CONTACT

jhjung@glpt.co.kr

82-31-739-5220 ext. 404

Facility Contacts

Hyeong-Seok Lim, MD, Ph D.

Role: primary

Other Identifiers

GLA5PR-107

Identifier Type: -

Identifier Source: org_study_id