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Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03775629
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Brief Summary:
This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Polmacoxib and Tramadol combination Drug: Polmacoxib Drug: Tramadol hydrochloride Phase 1

Detailed Description:

This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers.

Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each).

[Group A] 13 subjects will receive Tramadol HCl 300mg(150mg tablet *2) once/day (Administrate from D10 to 14) + 2 mg Polmacoxib capsule once/day for 14 days(2 mg Polmacoxib capsule from Day 3 ~ 14. But, 6 mg on DAY 1, 8 mg on Day 2) [Group B] Polmacoxib capsule once/day for 14 days (2 mg Polmacoxib capsule from Day 3 ~ 14. But, 6 mg on DAY 1, 8 mg on Day 2) [Group C] Tramadol HCl 300mg(150mg tablet *2) once /day for 5 days (Administrate from Day 1 to 5)

* [Treatment]

  • Group A: Tramadol hydrochloride (HCl) 300mg and polmacoxib 2mg combination regimen
  • Group B: Polmacoxib 2mg capsule
  • Group C: Tramadol hydrochloride (HCl) 300mg

Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline; Polmacoxib AUCmax, Cmax in either of whole blood and serum, tramadol HCl AUCmax, Cmax in serum. t1/2,SS, CL/F in whole blood will be evaluated as secondary endpoint.

Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group. Prevalence (%), average (SD) will be addressed using descriptive statistics.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A: Tramadol hydrochloride (HCl) 75mg tablet +Polmacoxib 2mg capsule combination regimen Group B: Polmacoxib 2mg capsule Group C: Tramadol hydrochloride (HCl) 75mg tablet
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG100650" in Healthy Volunteers
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Polmacoxib and Tramadol combination
Tramadol HCl 300mg once/day + 2 mg Polmacoxib capsule once/day for 14 days
Drug: Polmacoxib and Tramadol combination
Tramadol hydrochloride (HCl) 150mg, Polmacoxib 2mg

Active Comparator: Polmacoxib
Polmacoxib 2mg 14days
Drug: Polmacoxib
Polmacoxib 2mg

Active Comparator: Tramadol
Tramadol hydrochloride (HCl) 150mg 5days
Drug: Tramadol hydrochloride
Tramadol hydrochloride (HCl) 150mg
Other Name: Tramadol




Primary Outcome Measures :
  1. AUCtau of Polmacoxib in plasma [ Time Frame: 1Day, 3Day 6 Day, 10Day, 13 Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
  2. Cmax of Polmacoxib in plasma [ Time Frame: 1Day, 3Day 6 Day, 10Day, 13 Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
  3. AUCtau of Tramadol in plasma [ Time Frame: 1Day, 3 Day 4 Day, 5Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
  4. Cmax of Tramadol in plasma [ Time Frame: 1Day, 3 Day 4 Day, 5Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]

Secondary Outcome Measures :
  1. Cmax of Polmacoxib in Wole blood [ Time Frame: 1Day, 3Day 6 Day, 10Day, 13 Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
  2. AUC tau of Polmacoxib in Wole blood [ Time Frame: 1Day, 3Day 6 Day, 10Day, 13 Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
  3. Tmax ss [ Time Frame: 1Day, 3 Day 4 Day, 5Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration or 1Day, 3Day 6 Day, 10Day, 13D Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
    Polmacoxib in plasma and whole blood and Tramadol in plasma

  4. t1/2 [ Time Frame: 1Day, 3 Day 4 Day, 5Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration or 1Day, 3Day 6 Day, 10Day, 13D Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
    Polmacoxib in plasma and whole blood and Tramadol in plasma

  5. CL/F [ Time Frame: 1Day, 3 Day 4 Day, 5Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration or 1Day, 3Day 6 Day, 10Day, 13D Day, 14Day pre dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour after administration. ]
    Polmacoxib in plasma and whole blood and Tramadol in plasma



Information from the National Library of Medicine

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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. Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption
  5. Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)
  6. Edema or Fluid retention
  7. AST / ALT > 1.5 times the normal range including additional and Screening blood tests before randomization.
  8. MDRD < 60mL / min / 1.73m2 including additional and Screening blood tests before randomization.
  9. Any of the ECG result as below at Screening visit:

    • PR interval > 210 msec
    • QRS complex > 120 msec
    • QTcF > 450 msec
  10. Patient with an active peptic ulcer or gastrointestinal bleeding
  11. Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative colitis
  12. Patient with Congestive Heart Failure (NYHA II - IV)
  13. Established ischemic heart disease patients, peripheral arterial diseases, and/or brain vascular diseases patient
  14. patient with gastrointestinal related disease or gastrotomy history (except appendicitis or hernia surgery) that may affect the absorption of the investigational drug.
  15. Patient participated in any other clinical trials or Bio-equivalence studies within 90 days prior to the first administration of the investigational drug.
  16. 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.
  17. 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
  18. 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.
  19. Excessive Alcohol consumer 30 days prior to Screening visit (more than 24 glasses /week (1 glass =wine 150 ml, beer 360 ml, spirits 45 ml)) 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.
  20. Excessive caffeine consumer (> 5 drinks/ day)
  21. Patient cannot accept medically acceptable contraception during and until the clinical trial.
  22. 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): NCT03775629


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

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Kyung-sang Yu, Ph.D         
Contact: Sunwoo Jung, MD    +82-2-2072-4083    swj4991@gmail.com   
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
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Principal Investigator: Kyung-Sang Yu, Ph.D. Seoul National University Hospital

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Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT03775629     History of Changes
Other Study ID Numbers: CG100650-1-01
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents