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PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD. |
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| Cohort 2 | Experimental | Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD. |
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| Cohort 3 | Experimental | Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06678552 or Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). | 0 to 72 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552 |
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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 |
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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 |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| PF-06678552 or Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period. |
|
| PF-06678552 or Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period. |
|
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). |
| 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for for PF-06678552 | Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06678552 | Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Apparent Oral Clearance (CL/F) for PF-06678552 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Apparent Volume of Distribution (Vz/F) for PF-06678552 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927 | AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06644927 | Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06644927 | Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Amount of PF-06644927 excreted in the urine (Ae) | Amount of drug excreted in the urine is a measure of the degree that the kidneys filter drug from the blood to the urine. | 0-4, 4-12, and 12-24 hours post dose |
| Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%) | The percent of PF-06678552 dose excreted in the urine as PF-06644927 is calculated from the mass of dose excreted in the urine compared to the total dose of PF-06678552 and corrected for the relative weight of PF-06644927 to PF-06678552. | 0-4, 4-12, and 12-24 hours post dose |
| Renal Clearance (CLr) for PF-06644927 | Renal clearance is the measure of the rate of drug moving into the urine from blood | 0-4, 4-12, and 12-24 hours post dose |