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PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05190457 | Drug | Single Dose 2 mg |
| |
| PF-05190457 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PF-05190457 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 | 8 weeks | |
| The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit | 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), | 48 hour | |
| Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC) |
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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 | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33155163 | Derived | Cobbina E, Lee MR, Leggio L, Akhlaghi F. A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers. Clin Pharmacokinet. 2021 Apr;60(4):471-484. doi: 10.1007/s40262-020-00942-7. Epub 2020 Nov 5. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000606714 | PF-5190457 |
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| Drug |
Single Dose 10 mg |
|
| PF-05190457 | Drug | Single Dose 30 mg |
|
| PF-05190457 | Drug | Single Dose 100 mg |
|
| PF-05190457 | Drug | Single Dose 300 mg |
|
| PF-05190457 | Drug | Single Dose 600 mg |
|
| PF-05190457 | Drug | Single Dose - to be determined with food |
|
| PF-05190457 | Drug | Single Dose - to be determined |
|
| Placebo | Drug | Single Dose Placebo |
|
| Day 1 for Periods 1 and 2, for Cohort 3. |
| D004700 | Endocrine System Diseases |