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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO-13065, oral tablet | Experimental |
| |
| Placebo matched to NO-13065, oral tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO-13065 | Drug | Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. | Up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. | Up to 35 days |
| Area under the plasma concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koushi Iwata | Otsuka Pharmaceutical Factory, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Two subjects per cohort will take a matched placebo. |
|
To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
| Up to 35 days |
| Time to reach Cmax (Tmax) | To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. | Up to 35 days |
| Apparent first-order terminal elimination half-life (t ½) | To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects. | Up to 35 days |
| Correlation between QTc and NO-13065 plasma concentrations | To explore the correlation between changes in QTc interval (msec) and NO-13065 plasma concentrations, appropriate correction method for QTc interval calculation such as QTcF will used for analysis. | Up to 29 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |