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B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.
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The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg PF-05190457 or Placebo BID | Experimental |
| |
| 10 mg PF-05190457 or Placebo BID | Experimental |
| |
| 40 mg PF-05190457 or Placebo BID | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. |
|
| 150 mg PF-05190457 or Placebo BID | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. |
|
| 5 mg PF-05190457 or Placebo QD | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. |
|
| 50 mg PF-05190457 or Placebo QD | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05190457 or Placebo | Drug | Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events as a measure of safety and tolerability. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit. | 2 weeks | |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit. |
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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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| ID | Term |
|---|---|
| C000606714 | PF-5190457 |
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| xxx mg PF-05190457 or Placebo | Experimental | Dose and dose frequency to be determined based on emerging safety and PK data. |
|
| PF-05190457 or Placebo | Drug | Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. |
|
| PF-05190457 or Placebo | Drug | Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. |
|
| PF-05190457 or Placebo | Drug | Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. |
|
| PF-05190457 or Placebo | Drug | Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers. |
|
| PF-05190457 or Placebo | Drug | Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers. |
|
| PF-05190457 or Placebo | Drug | Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients. |
|
| 2 weeks |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit. | 2 weeks |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit. | 2 weeks |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit. | 2 weeks |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit. | 2 weeks |
| The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit. | 2 weeks |
| Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit. | 2 weeks |
| D004700 | Endocrine System Diseases |