Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01154764
First received: March 10, 2010
Last updated: February 13, 2013
Last verified: February 2013

March 10, 2010
February 13, 2013
October 2009
March 2010   (final data collection date for primary outcome measure)
pharmacokinetic evaluation [ Time Frame: 2 month ] [ Designated as safety issue: No ]
AUClast, Cmax, tmax, AUCinf, t1/2β After administration, the concentration of CG100649 in Plasma
Same as current
Complete list of historical versions of study NCT01154764 on ClinicalTrials.gov Archive Site
Safety evaluation-No adverse events [ Time Frame: 2 month ] [ Designated as safety issue: Yes ]
BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test.
Same as current
Not Provided
Not Provided
 
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers

This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

  • Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
  • Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parameters. Concentrations below the lower limit of quantification, samplings which are not applicable, or missing data will be substituted by "<LLOQ", "NA", or "MD" respectively. Pharmacokinetic analyses will be performed on CG100649 only.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: CG100649
    I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days
    Other Name: CG100649 and ketoconazole
  • Drug: CG100649 and ketoconazole
    I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days
    Other Name: CG100649 and ketoconazole
  • Experimental: CG100649
    study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.
    Interventions:
    • Drug: CG100649
    • Drug: CG100649 and ketoconazole
  • Experimental: CG100649 and ketoconazole
    study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.
    Interventions:
    • Drug: CG100649
    • Drug: CG100649 and ketoconazole
Youn Choi H, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of ketoconazole on the pharmacokinetic properties of CG100649, a novel NSAID: a randomized, open-label crossover study in healthy Korean male volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. doi: 10.1016/j.clinthera.2013.12.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
  2. No significant chronic/congenital disease
  3. Normal results for lab test
  4. Ability of informed consent

Exclusion Criteria:

  1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
  3. History of known hypersensitivity to drugs including CG100649.
  4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
Male
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01154764
CG100649-1-03
No
CrystalGenomics, Inc.
CrystalGenomics, Inc.
Not Provided
Principal Investigator: Hyeong-Seok Lim, MD, PhD Seoul Asan medical Center
CrystalGenomics, Inc.
February 2013

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