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Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single-ascending cohort 1 |
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| Cohort 2 | Experimental | Single-ascending cohort 2 |
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| Cohort 3 | Experimental | Single-ascending cohort 3 |
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| Cohort 4 | Experimental | Single-ascending cohort 4 |
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| Cohort 5 | Experimental | Single-ascending cohort 5 |
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| Cohort 6 | Experimental | Multiple-ascending cohort 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 (JP-1366 A mg) | Drug | Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose |
| AUClast | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose |
| AUCinf | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose |
| tmax | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose |
| t1/2 | SAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose |
| Cmax,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| Cmin,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| Cav,ss |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital(SNUH) | Seoul | Jongno-Gu | 110-744 | South Korea |
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| Cohort 7 |
| Experimental |
Multiple-ascending cohort 2 |
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| Cohort 8 | Experimental | Multiple-ascending cohort 3 |
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| Cohort 9 | Experimental | Multiple-ascending cohort 4 |
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| Cohort 2 (JP-1366 B mg) | Drug | Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 3 (JP-1366 C mg) | Drug | Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 4 (JP-1366 D mg) | Drug | Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 5 (JP-1366 E mg) | Drug | Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 6 (JP-1366 F mg) | Drug | Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 7 (JP-1366 G mg) | Drug | Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 8 (JP-1366 H mg) | Drug | Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg |
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| Cohort 9 (JP-1366 I mg) | Drug | Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg |
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MAD endpoint
| Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| AUCĪ | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| tmax,ss | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| t1/2 | MAD endpoint | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose |
| Percentage of total time that the intragastric pH was above 4 | SAD | 0-24 hours(Day -1), 0-24 hours(Day 1) |
| Percentage of total time that the intragastric pH was above 4 | MAD | 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7) |
| Serum gastrin concentration | SAD | Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose |
| Serum gastrin concentration | MAD | Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose |
| ID | Term |
|---|---|
| C110804 | mycophenolic adenine dinucleotide |
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