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The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 2 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 3 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 4 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 5 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 6 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTT-251 or Placebo | Drug | Subjects will receive JTT-251 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 1 week | |
| Vital signs and 12 lead ECGs | 1 week | |
| Cmax (maximum concentration) | 1 week | |
| t1/2 (elimination half-life) | 1 week | |
| AUC (area under the concentration-time curve) | 1 week | |
| fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval) | 1 week |
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Inclusion Criteria:
Healthy Subject Cohorts:
Type 2 Diabetic Subject Cohorts:
Exclusion Criteria:
Healthy Subject Cohorts:
Type 2 Diabetic Subject Cohorts:
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| Name | Affiliation | Role |
|---|---|---|
| Hideyuki Yamamoto | Akros Pharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Dose 7 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
|
| Dose 8 JTT-251 or Placebo | Experimental | Tablets, single dose in fed condition |
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| Dose 9 JTT-251 or Placebo | Experimental | Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition |
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