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This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05175157, Midazolam | Experimental | Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 |
|
| Placebo, Midazolam | Experimental | Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05175157 | Drug | 200 mg tablet administered twice per day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma PF-05175157 Concentration (Cmax) | Single Dose | 0 - 10 hrs postdose |
| Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) | Single Dose | 0 - 10 hrs postdose |
| Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) | Single Dose | 0 - 10 hrs postdose |
| Maximum Observed Plasma PF-05175157 Concentration (Cmax) | Steady State | 0 - 48 hours postdose |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 | Steady State | 0 - 48 hours postdose |
| Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) | Steady State | 0 - 48 hours postdose |
| Apparent Oral Clearance of PF-05175157 (CL/F) | 0 - 48 hours postdose | |
| Accumulation Ratio of PF-05175157 (Rac) | 0 - 10 hours postdose | |
| Plasma Decay Half-Life of PF-05175157 (t1/2) |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
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 | Chula Vista | California | 91911 | 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 |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
2mg administered as single doses on Days 0 and 11 |
|
| Placebo | Other | Placebo administered twice per day for 14 days |
|
| Midazolam | Drug | 2mg administered as single doses on Days 0 and 11 |
|
| 0 - 48 hours postdose |
| Apparent Volume of Distribution of PF-05175157 (Vz/F) | 0 - 48 hours postdose |
| Urinary Recovery for PF-05175157 (AE24) | Amount of PF-05175157 recovered in urine over 24 hours | 0 - 24 hours postdose |
| Renal Clearance for PF-05175157 (CLr) | 0 - 24 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] | 0 - 48 hours postdose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] | 0 - 48 hours postdose |
| Maximum Observed Plasma Concentration for midazolam (Cmax) | 0 - 48 hours postdose |
| Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) | 0 - 48 hours post dose |
| Plasma Decay Half-Life of midazolam (t1/2) | 0 - 48 hours postdose |
| Fasting triglycerides | 14 days |
| Total cholesterol | 14 days |
| LDL cholesterol | 14 days |
| HDL cholesterol | 14 days |
| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |