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

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ClinicalTrials.gov Identifier: NCT03774355
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Tracking Information
First Submitted Date  ICMJE December 9, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE December 17, 2018
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03774355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
Official Title  ICMJE A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CG1801
    Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
  • Drug: CGL1802
    Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
Study Arms  ICMJE
  • Experimental: CG1801
    Dosing 'CG1801' followed by dosing 'CGL1802'
    Intervention: Drug: CG1801
  • Experimental: CGL 1802
    Dosing 'CGL1802' followed by dosing 'CG1801'
    Intervention: Drug: CGL1802
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2019
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sangsook Cho, Ph.D +82 31 628 2873 scho@cgxinc.com
Contact: Chohee Park +82 31 628 2872 chpark@cgxinc.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774355
Other Study ID Numbers  ICMJE CG100649-1-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CrystalGenomics, Inc.
Study Sponsor  ICMJE CrystalGenomics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung-Sang Yu, Ph.D. Seoul National University Hospital
PRS Account CrystalGenomics, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP