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The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTK-853 (fasted condition) | Experimental |
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| Dose 2 JTK-853 (fasted condition) | Experimental |
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| Dose 3 JTK-853 (fasted condition) | Experimental |
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| Dose 2 JTK-853 (fed condition) | Experimental |
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| Dose 3 JTK-853 (fed condition) | Experimental |
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| Dose 4 JTK-853 (fed condition) | Experimental |
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| Dose 5 JTK-853 (fed condition) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTK-853 or Placebo | Drug | Tablets, single dose, fasted, fed or high-fat fed condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 1 week | |
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 | 1 week | |
| Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2 | 1 week | |
| Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2 | 1 week | |
| Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2 | 1 week | |
| Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shoji Hoshino, D.V.M | Akros Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD, Phase I Clinic | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C578010 | JTK-853 |
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| Dose 6 JTK-853 (fed condition) |
| Experimental |
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| Dose 7 JTK-853 (fed condition) | Experimental |
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| Dose 5 JTK-853 (high-fat fed condition) | Experimental |
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| Placebo | Placebo Comparator |
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