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The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 2 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 3 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 4 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 5 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 6 JTT-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTT-252 or Placebo | Drug | Subjects will receive JTT-252 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 22 days | |
| Vital signs and 12 lead ECGs | 22 days | |
| Cmax (maximum concentration) | 22 days | |
| t1/2 (elimination half-life) | 22 days | |
| AUC (area under the concentration-time curve) | 22 days | |
| fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval) | 3 days | |
| Plasma glucose | 22 days |
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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 |
|---|---|---|
| Yuichiro Neki | Akros Pharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | 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-252 or Placebo | Experimental | Tablets, single dose in fasted condition |
|
| Dose 8 JTT-252 | Experimental | Tablets, single dose in fed condition |
|
| Dose 9 JTT-252 | Experimental | Tablets, single dose in fasted condition |
|
| JTT-252 | Drug | Subjects will receive JTT-252 |
|
| Austin |
| Texas |
| United States |