Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
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ClinicalTrials.gov Identifier: NCT01154764 |
Recruitment Status :
Completed
First Posted : July 1, 2010
Last Update Posted : February 15, 2013
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: CG100649 Drug: CG100649 and ketoconazole | Phase 1 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
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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.
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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 |
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.
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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 |
- pharmacokinetic evaluation [ Time Frame: 2 month ]AUClast, Cmax, tmax, AUCinf, t1/2β After administration, the concentration of CG100649 in Plasma
- Safety evaluation-No adverse events [ Time Frame: 2 month ]BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test.

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Ages Eligible for Study: | 19 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154764
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Hyeong-Seok Lim, MD, PhD | Seoul Asan medical Center |
Responsible Party: | CrystalGenomics, Inc. |
ClinicalTrials.gov Identifier: | NCT01154764 |
Other Study ID Numbers: |
CG100649-1-03 |
First Posted: | July 1, 2010 Key Record Dates |
Last Update Posted: | February 15, 2013 |
Last Verified: | February 2013 |
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