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| Name | Class |
|---|---|
| Profil Institute for Clinical Research, Inc. | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P7435 | Experimental |
|
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P7435 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (single and multiple dose studies) | - To determine the safety and tolerability of single (Part A) and multiple (Part B) ascending doses of P7435 in healthy, overweight or obese subjects | 12-14 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Food Effect |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Elaine Watkins | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facility: Profil® Institute for Clinical Research, Inc. | Chula Vista | California | 91911 | United States |
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|
| 12-14 Months |
| Area under the plasma concentration (AUC) | Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state. | 12- 14 Months |
| Peak Plasma concentration (Cmax) | Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state. | 12- 14 Months |
| Time to peak plasma concentration (t-max) | Part A: The PK profile will be derived from the P7435 plasma concentration data on Day 1. Part B: The PK profile will be derived from the P7435 plasma concentration data on Days 1 and 10. Trough levels will be compared to assess steady state. | 12- 14 Months |
| Change in Fasting serum lipids | - Fasting serum lipids [total cholesterol, triglycerides, low-density lipoproteins (LDL C), high-density lipoproteins (HDL-C), very-low-density lipoproteins (VLDL), free fatty acids and apolipoprotein-B (Apo-B)] (Part B only) | 12- 14 Month |
| Change in Fasting plasma glucose | Part B only | 12- 14 Months |
| Fat tolerance test | - Fat tolerance test variables including peak and post-prandial glucose, insulin, C peptide, lipids, GLP-1 and GIP and inflammatory biomarkers such as malondialdehyde and β-hydroxy butyrate (Part A and B) | 12- 14 month |
| Fasting serum insulin | Part B only | 12 - 14 months |
| Fasting serum C-peptide | Part B only | 12-14 months |