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Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

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ClinicalTrials.gov Identifier: NCT01154764
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CG100649 Drug: CG100649 and ketoconazole Phase 1

Detailed Description:
  • 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers
Study Start Date : October 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. pharmacokinetic evaluation [ Time Frame: 2 month ]
    AUClast, Cmax, tmax, AUCinf, t1/2β After administration, the concentration of CG100649 in Plasma


Secondary Outcome Measures :
  1. Safety evaluation-No adverse events [ Time Frame: 2 month ]
    BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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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): NCT01154764


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
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Principal Investigator: Hyeong-Seok Lim, MD, PhD Seoul Asan medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01154764    
Other Study ID Numbers: CG100649-1-03
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by CrystalGenomics, Inc.:
healthy male volunteers
Additional relevant MeSH terms:
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Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors