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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 multiple oral doses of PF-06678552 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
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| Cohort 2 | Experimental | Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
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| Cohort 3 | Experimental | Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
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| Cohort 4 | Experimental | Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
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| Cohort 5 | Experimental | Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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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 by 12 lead ECG. | 0 to 24 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7 |
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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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| Cohort 6 | Experimental | Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
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| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
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| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
|
| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. |
|
| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days. |
|
| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days. |
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| PF-06678552 | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days. |
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| Placebo | Drug | PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days. |
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| 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Amount of PF-06644927 excreted in urine (Ae) on day 14 | 0-12 hours post dose |
| Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14 | 0-12 hours post dose |
| Renal clearance of PF-06644927 (CLr) on day 14 | 0-12 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1 | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Apparent Oral Clearance (CL/F) of PF-06678552 on day 7 | 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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Apparent Oral Clearance (CL/F) of PF-06678552 on day 14 | 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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7 | 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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |
| Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14 | 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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose |