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PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days |
|
| PF-06427878 | Experimental | PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo as suspension administered every 8 hours, with food |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Treatment-Related Adverse Events (AEs) | Day -2 to Day 44 | |
| Change from baseline in clinical laboratory tests | Day 1 to Day 22 | |
| Change from baseline in vital signs | Day 0 to Day 22 | |
| Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram | Day 0 to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
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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 |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States | ||
| Qps-Mra, Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776293 | Derived | Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| PF-06427878 |
| Drug |
500 mg suspension administered every 8 hours, with food |
|
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Apparent Oral Clearance (CL/F) of PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Peak:Trough ratio of PF-06427878 on day 14 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1 | 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose |
| Amount of PF-06427878 excreted in urine (Ae) on day 14 | 0-8 hours post dose |
| Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14 | 0-8 hours post dose |
| Renal clearance of PF-06427878 (CLr) on day 14 | 0-8 hours post dose |
| South Miami |
| Florida |
| 33143 |
| United States |