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The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTK-853, 400 mg ketoconazole | Experimental |
| |
| Dose 2 JTK-853 | Experimental |
| |
| Dose 3 JTK-853 | Experimental |
| |
| Dose 4 JTK-853 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTK-853, ketoconazole | Drug | JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 | 3 weeks | |
| Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2 | 3 weeks | |
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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 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| JTK-853 or Placebo | Drug | JTK-853 Tablets or Placebo, twice a day for 14 days |
|
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 |
| 3 weeks |
| Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2 | 3 weeks |
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration | 3 weeks |
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration | 3 weeks |