Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CrystalGenomics, Inc.
• Treatments: Ketoconazole

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).