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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04620110 | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04620110 | Drug | Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements. | Baseline to 2 weeks | |
| To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects. | Baseline to 2 weeks | |
| To characterize the effect of PF-04620110 on postprandial lipid metabolism measures. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. | Day -1 and Day 14 | |
| Secondary Pharmacodynamic Endpoints in response to a liquid meal test | Day -1 and Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36690550 | Derived | Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C582730 | PF-04620110 |
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| Placebo | Drug | Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria. |
|
| Triglyceride excursions | Day -1, Day 1, and Day 14 |
| Glucose, insulin, and C-peptide excursions | Day -1 and Day 14 |
| Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY | Day -1 and Day 14 |
| Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin | Day -1 and Day 14 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |