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The study was terminated on October 29, 2010 due to gastrointestinal adverse events.
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The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg PF-05161704 or Placebo | Experimental |
| |
| 15 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. |
|
| 50 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. |
|
| 150 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. |
|
| xx mg PF-05161704 or Placebo | Experimental | Planned dose and dosing regimen will be determined based on emerging PK and safety data. |
|
| xxx mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 5 arms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring | 2 weeks | |
| Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL | 2 weeks | |
| Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight |
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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 |
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| 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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|
| yy mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 6 arms |
|
| yyy mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 7 arms. |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast |
|
| PF-05161704 or Placebo | Drug | PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast |
|
| 2 weeks |
| D004700 | Endocrine System Diseases |