ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 292139 for:    ALL
Previous Study | Return to List | Next Study

Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03774355
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Brief Summary:
The objective of this open-label, randomized, 2*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: CG1801 Drug: CGL1802 Phase 1

Detailed Description:
Healthy volunteers are administrated single-dose over the period I and II (crossover) of CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
Estimated Study Start Date : December 17, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Arm Intervention/treatment
Experimental: CG1801
Dosing 'CG1801' followed by dosing 'CGL1802'
Drug: CG1801
Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.

Experimental: CGL 1802
Dosing 'CGL1802' followed by dosing 'CG1801'
Drug: CGL1802
Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2




Primary Outcome Measures :
  1. Area Under Curve [AUC]last of polmacoxib in Whole blood AUClast of polmacoxib in Whole blood AUClast of polmacoxib in Whole blood AUClast of polmacoxib in Whole blood [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
    Area Under Curve [AUC]last of CGL1802 will be evaluated the T/R ratio compare the CG1801.

  2. Maximum Plasma Concentration [Cmax] of polmacoxib in Whole blood [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
    Maximum Plasma Concentration [Cmax] of CGL1802 will be evaluated the T/R ratio compare the CG1801


Secondary Outcome Measures :
  1. Area Under Curve [AUC]last of polmacoxib in Serum [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  2. Maximum Plasma Concentration [Cmax] of polmacoxib in serum [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  3. AUCinf of polmacoxib [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  4. Time to maximum plasma concentration [Tmax] of polmacoxib [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  5. t1/2 of polmacoxib [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  6. clearance [CL/F] of Polmacoxib [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]
  7. Volume of distribution [Vd/F] of Polmacoxib [ Time Frame: Day1 predose and 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 hours post dose) and 72 (4Day), 144 (7days), 192 (9days), 240 (11days), 336 (15days), 504 (22days), 672 (29days) hours of each of the 2 treatment periods in CG1801 and CGL1802 Group. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female aged ≥ 19 years and ≤ 50 years
  2. Without inborn or chronic disease and no symptoms in physical examination
  3. BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2
  4. Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on
  5. After taking a rest in sitting position for 5 minutes, subjects who have blood pressure (90 mmHg ≤ Systolic BP ≤ 139 mmHg, and 60 mmHg ≤ Diastolic BP ≤ 89 mmHg)
  6. Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation
  7. Negative pregnancy test(hCG) and agree to contraception during the trial

Exclusion Criteria:

  1. History of hypersensitivity to investigational products
  2. History of hypersensitivity or allergic reaction to sulfonamide.
  3. Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)
  4. Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)
  5. Edema or Fluid retention
  6. AST / ALT > 1.5 times the normal range including additional and Screening blood tests before randomization.
  7. MDRD < 60mL / min / 1.73m2 including additional and Screening blood tests before randomization.
  8. Patient with an active peptic ulcer or gastrointestinal bleeding
  9. Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative colitis
  10. Patient with Congestive Heart Failure (NYHA II - IV)
  11. Established ischemic heart disease patients, peripheral arterial diseases, and/or brain vascular diseases patient
  12. Patient performed CABG within 30 days prior to the first administration of the investigational drug
  13. Patient has hyperkalemia
  14. Patient has blood coagulation disorder or administration the anticoagulant
  15. Patient with gastrointestinal related disease or gastrotomy history (except appendicitis or hernia surgery) that may affect the absorption of the investigational drug.
  16. Patient participated in any other clinical trials or Bio-equivalence studies within 90 days prior to the screening visit.
  17. Patient donated whole blood within 60 days, donated blood component within 14 days, or received blood transfusion within 30 days prior to the first administration of the investigational drug.
  18. Taken medications like barbital or herbal medicines within 30 days or taken Over The Counter medicines within 7 days prior to the first administration of the investigational drug that may affect the clinical trial
  19. Over smokers (tobacco > 20 cigarettes/ days) within 30 days prior to Screening visit or patient cannot quit smoking during and until the end of the clinical trial after signed the Informed Consent Form to participate the clinical trial.
  20. Excessive Alcohol consumer 30 days prior to Screening visit or cannot quit drinking alcohol during and until the end of the clinical trial after signed the Informed Consent Form to participate the clinical trial.
  21. Excessive caffeine consumer (> 5 drinks/ day)
  22. Breast Feeding woman
  23. Patient cannot accept medically acceptable contraception during and until the clinical trial.
  24. Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774355


Contacts
Contact: Sangsook Cho, Ph.D +82 31 628 2873 scho@cgxinc.com
Contact: Chohee Park +82 31 628 2872 chpark@cgxinc.com

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Principal Investigator: Kyung-Sang Yu, Ph.D. Seoul National University Hospital

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT03774355     History of Changes
Other Study ID Numbers: CG100649-1-07
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No