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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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 |
|
| Group 2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG100649 | Drug | I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 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 | |
| AUClast | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeong-Seok Lim, MD, PhD | Seoul Asan medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24417786 | Derived | Youn Choi H, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of ketoconazole on the pharmacokinetic properties of CG100649, a novel NSAID: a randomized, open-label crossover study in healthy Korean male volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. doi: 10.1016/j.clinthera.2013.12.004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Period 1: CG100649 (1 mg x 6 capsules) once a day, 1 Day Period 2: CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets) once a day for 4 days (Days 2-5), for a total of 5 days. |
| FG001 | Group 2 | Period 1: CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets) once a day for 4 days (Days 2-5), for a total of 5 days. Period 2: CG100649 (1 mg x 6 capsules) once a day, 1 Day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (5days) |
| |||||||||||||
| Intervention 2 (5days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 and Group 2 | Overall Demographic Character |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CG100649 6mg Single Dosing | CG100649 (1 mg x 6 capsules), once a day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyeong-Seok Lim MD, Ph.D | Asan Medical Center | +82 2 3010 4613 | mdihs@amc.seoul.kr |
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| ID | Term |
|---|---|
| C000599293 | CG100649 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole | Drug | I period: ketoconazole + CG100649 II period: CG 100649 |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | AUClast | Posted | Mean | Standard Deviation | h∙ng/mL | 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 |
|
|
|
| 0 |
| 28 |
| 6 |
| 28 |
| EG001 | CG100649+ Ketoconazole | CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets), once a day for 4 days (Days 2-5), for a total of 5 days. | 0 | 28 | 7 | 28 |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hematuria | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Pyuria | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Clavicle Fractuer | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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