Status:
COMPLETED
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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.
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 ...
Eligibility Criteria
Inclusion
- Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
- No significant chronic/congenital disease
- Normal results for lab test
- Ability of informed consent
Exclusion
- History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- History of known hypersensitivity to drugs including CG100649.
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01154764
Start Date
October 1 2009
End Date
December 1 2010
Last Update
January 3 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea