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PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-04620110 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects will be given placebo or PF-04620110 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements. | 4 days/dose group | |
| The single dose pharmacokinetics of PF-04620110 will be assessed | 4 days/dose group |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures | 1 day/dose group |
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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 |
|---|---|
| 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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| PF-04620110 |
| Drug |
A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |