Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000130-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 of multiple oral doses of PF-06427878 in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
|
| Cohort 2 | Experimental | Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
|
| Cohort 3 | Experimental | Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
|
| Cohort 4 | Experimental | Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
|
| Cohort 5 | Experimental | Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06427878 | Drug | PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events (AEs). | 0-25 days | |
| Assessment of clinical laboratory tests. | 0-25 days | |
| Assessment of vital signs (including blood pressure and pulse rate). | 0-25 days | |
| Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). | 0-25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose | |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cohort 6 | Experimental | Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. |
|
| Placebo | Drug | Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2). |
|
| PF-06427878 | Drug | PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8). |
|
| Placebo | Drug | Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2). |
|
| 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 | 0, 1, 2, 3, 4, 6, 8, 12 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 | 0, 1, 2, 3, 4, 6, 8, 12 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |
| Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |
| Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |