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A study for estimation of predictive factors which are related with drug response variability of COX-2 selective inhibitor in Korean healthy subjects

Status Approved

First Submitted Date

2016/08/01
Registered Date

2019/05/21
Last Updated Date

2019/04/15

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003958
Unique Protocol ID	15-031
Public/Brief Title	A study for estimation of predictive factors which are related with drug response variability of COX-2 selective inhibitor in Korean healthy subjects
Scientific Title	A study for estimation of predictive factors which are related with drug response variability of COX-2 selective inhibitor in Korean healthy subjects
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	15-031
Approval Date	2015-03-18
Institutional Review Board Name	Dong-A University Hospital Institutional review board
Institutional Review Board Address	26, Daesingongwon-ro, Seo-gu, Busan, Republic of Korea
Institutional Review Board Telephone	051-240-2572
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Min-kyu Park
Title	Ph.D
Telephone	+82-51-240-5180
Affiliation	Dong-A University Hospital
Address	Dep. of Clinical Pharmacology& Therapeutics, 9F Center Building, Dong-A University Hospital, #26, Daeshingongwon-ro, Seo-gu, Busan
Contact Person for Public Queries
Name	Min-kyu Park
Title	Ph.D
Telephone	+82-51-240-5180
Affiliation	Dong-A University Hospital
Address	Dep. of Clinical Pharmacology& Therapeutics, 9F Center Building, Dong-A University Hospital, #26, Daeshingongwon-ro, Seo-gu, Busan
Contact Person for Updating Information
Name	Min-kyu Park
Title	Ph.D
Telephone	+82-51-240-5180
Affiliation	Dong-A University Hospital
Address	Dep. of Clinical Pharmacology& Therapeutics, 9F Center Building, Dong-A University Hospital, #26, Daeshingongwon-ro, Seo-gu, Busan

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Terminated
Date of First Enrollment	2015-04-10 Actual
Target Number of Participant	24
Primary Completion Date
Study Completion Date
Name of Study	Dong-A University Hospital
Recruitment Status	Terminated Terminated Reason : 유전형 적합 대상자 부족
Date of First Enrollment	2015-04-10 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Dong-A University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Dong-A University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The clinical trial is conducted to analyze pre-selected COX-2 SNP (single nucleotide polymorphism) factor after administration of COX-2 selective inhibitor, compare and evaluate the pharmacokinetic characteristics of each COX-2 SNP factor to the COX-2 selective inhibitor and the inhibition of COX-2 activation in blood

Study Summary Information

Lay Summary

The clinical trial is conducted to analyze pre-selected COX-2 SNP (single nucleotide polymorphism) factor after administration of COX-2 selective inhibitor, compare and evaluate the pharmacokinetic characteristics of each COX-2 SNP factor to the COX-2 selective inhibitor and the inhibition of COX-2 activation in blood

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Basic Science
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Genetic
Intervention Description	1. Target gene : rs5275(T->C) 1)SNP type : TT -Number of Subjects :4 2)SNP type : TC -Number of Subjects : 4 3)SNP type : CC -Number of Subjects : 4 2. Target gene : rs689466(A->G) 1)SNP type : AA -Number of Subjects : 4 2)SNP type : AG -Number of Subjects : 4 3)SNP type : GG -Number of Subjects : 4 -Test drug : Celecoxib -Compare and evaluate the pharmacokinetic characteristics of each COX-2 SNP factor to the COX-2 selective inhibitor and the inhibition of COX-2 activation in blood after administration
Number of Arms	6
Arm 1	Arm Label TT SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs5275(T->C) SNP type : TT Test drug : Celecoxib
Arm 2	Arm Label TC SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs5275(T->C) SNP type : TC Test drug : Celecoxib
Arm 3	Arm Label CC SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs5275(T->C) SNP type : CC Test drug : Celecoxib
Arm 4	Arm Label AA SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs689466(A->G) SNP type : AA Test drug : Celecoxib
Arm 5	Arm Label AG SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs689466(A->G) SNP type : AG Test drug : Celecoxib
Arm 6	Arm Label GG SNP type
	Target Number of Participant 4
	Arm Type Experimental
	Arm Description Target gene : rs689466(A->G) SNP type : GG Test drug : Celecoxib

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M13.99)Arthritis, unspecified, site unspecified 1. Signs or symptoms of osteoarthritis(degenerative arthritis) 2. Signs or symptoms of rheumatoid arthritis 3. Signs or symptoms of ankylosing spondylitis 4. Acute pain(postoperative or after dental extraction) in adults 5. Primary dysmenorrhea
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~50Year
	Description 1. A subject who meets the standards of SCR completion among the participants who took part in the previous study (14-071) and completed the gene examination of four types of SNP 2. Healthy man aged between 19 and 50 (inclusive) at the time of the screening 3. A subject with a body weight over 55 kg (inclusive) and with body mass index (BMI) between 18 (inclusive) and 30 (inclusive) 4. A subject who is willing to make himself available for the study period and follow the study protocol and provides written informed consent after fully understanding the study procedures
Exclusion Criteria	1. A subject who has any clinically significant past or present medical history of liver disease, kidney disease, nervous system disease, respiratory system disease, endocrine system disease, hemato-oncology disease, urinary system disease, cardiovascular system disease, musculoskeletal system disease or mental disorder 2. A subject with past history of gastrointestinal disease (e.g., Crohn’s disease, ulcer, acute or chronic pancreatitis, and others) or surgery (except for simple appendectomy or repair of a hernia, endoscopic submucous resection and endoscopic polypectomy), which can influence the absorption of investigational product. 3. A subject with any hypersensitivity to drugs including celecoxib and other drugs (e.g., aspirin, antibiotics, and others) or any history of clinically significant hypersensitivity 4. A subject with any clinically significant findings in ECG at the time of screening as follows: QTc> 450 msec, PR interval > 200 msec; QRS duration > 120 5. A subject who has the following vital signs results in sitting position after he rests for at least 3 minutes at the time of the screening : SBP ≤ 100 mmHg or DBP ≤ 60 mmHg; SBP ≥ 160 mmHg or DBP ≥ 95 mmHg 6. A subject who has taken any ethical-the-counter drug or herbal compound within 2 weeks prior to the administration of the study drug or has taken any over-the-counter drug or vitamin supplement within 1 week before the investigational product administration (If, however, the drugs are determined not to be effective in pharmacokinetic profiles, the subjects can participate in the study according to the judgment of the investigator.). 7. A subject who has participated in any other clinical and had medication within 2 months prior to the first administration of investigational product (If five times the pharmacokinetic half-life of the medication passes, the subject can participate in the study). 8. A subject who has donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 1 month prior to the administration of investigational product. 9. A subject who consistently drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or is not able to stop drinking throughout the clinical trial. 10. A smoker who consumes more than 10 cigarettes on average a day for recent 3 months and who is unable to stop smoking during the study. 11. A subject who eats or drinks products containing grapefruit and who is unable to stop eating or drinking throughout the study period, from 48 hours before the first administration to the post-study visit. 12. A subject who takes or who is unable to stop eating or drinking products containing caffeine (coffee, green tea, black tea, soda, coffee flavored milk, nutritious tonic, and others) from 24 hours prior to the administration to the point of discharge 13. A subject who is not eligible for the study due to clinical laboratory results or other reasons on the investigators’ judgment.
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	&Pharmacokinetics/dynamics
Outcome	Celecoxib's AUClast, Cmax
Timepoint	Pre-dose (0 h) and post-dose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 h (Total 11 times)
Primary Outcome(s) 2
Outcome	Lipopolysaccharide induced by COX-2 (Cyclooxygenase-2) activity assay
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)
Primary Outcome(s) 3
Outcome	COX-2 (Cyclooxygenase-2) mRNA and protein assay
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)
Primary Outcome(s) 4
Outcome	COX-1 (Cyclooxygenase-1) activity assay (TXB2)
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)
Primary Outcome(s) 5
Outcome	Light transmittance aggregometry (% of inhibition)
Timepoint	Pre-dose (0h) and Post-dose 4, 8, 12, 24, 48 h
Secondary Outcome(s) 1
Outcome	Celecoxib's AUCinf, Tmax, t1/2, CL/F, Vd/F
Timepoint	Pre-dose (0 h) and post-dose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 h (Total 11 times)
Secondary Outcome(s) 2
Outcome	AChE (Acetylcholineesterase) activity
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)
Secondary Outcome(s) 3
Outcome	BChE (Butyrylcholinesterase) activity
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)
Secondary Outcome(s) 4
Outcome	PON-1 (Paraoxonase/arylesterase-1) activity
Timepoint	Pre-dose (0 h) and Post-dose 2, 4, 8, 12, 24, 48 h (Total 7 times)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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