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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
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: CG100649
Drug: CG100649 and ketoconazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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.
 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

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.
  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154764

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Principal Investigator: Hyeong-Seok Lim, MD, PhD Seoul Asan medical Center
  More Information

No publications provided

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01154764     History of Changes
Other Study ID Numbers: CG100649-1-03
Study First Received: March 10, 2010
Last Updated: February 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:
healthy male volunteers

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013