Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CG100649
* Drug: CG100649 and ketoconazole


Participation Criteria
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Eligibility Criteria
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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 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).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG100649<br>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<br>* I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days<br>* Other names: CG100649 and ketoconazole;Drug: CG100649 and ketoconazole<br>* I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days<br>|
| Experimental: CG100649 and ketoconazole<br>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<br>* I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days<br>* Other names: CG100649 and ketoconazole;Drug: CG100649 and ketoconazole<br>* I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic evaluation | AUClast, Cmax, tmax, AUCinf, t1/2β After administration, the concentration of CG100649 in Plasma | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation-No adverse events | BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test. | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy male volunteers