A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CG100649
- Conditions
- Healthy
- Sponsor
- CrystalGenomics, Inc.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- AUClast
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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 CG
- •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).
Arms & Interventions
Group 1
Period 1: CG100649 will be administered alone on Day 1 -After washout period- Period 2: The combination of CG100649 and ketoconazole tabs together on Day 1 followed by ketoconzzole tabs
Intervention: CG100649
Group 1
Period 1: CG100649 will be administered alone on Day 1 -After washout period- Period 2: The combination of CG100649 and ketoconazole tabs together on Day 1 followed by ketoconzzole tabs
Intervention: Ketoconazole
Group 2
Period 1: The combination of CG100649 and ketoconazole tabs will be administered together on Day 1, followed by ketoconazole tabs for 4 days, for a total of 5 days. -After washout period- Period 2: CG100649 alone
Intervention: CG100649
Group 2
Period 1: The combination of CG100649 and ketoconazole tabs will be administered together on Day 1, followed by ketoconazole tabs for 4 days, for a total of 5 days. -After washout period- Period 2: CG100649 alone
Intervention: Ketoconazole
Outcomes
Primary Outcomes
AUClast
Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose
Cmax
Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose