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Also known as [11C]PF-06427878
PF-06427878 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 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 |
| [11C]PF-06427878 | EXPERIMENTAL | Single intravenous infusion of \[11C\]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
| PF-06427878 10 mg | EXPERIMENTAL | Single oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
| PF-06427878 600 mg | EXPERIMENTAL | Single oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
| 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. |
| 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. |
| Cohort 1-PF-06427878 or placebo | EXPERIMENTAL | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
| Cohort 2-PF-06427878 or placebo | EXPERIMENTAL | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
| Cohort 3-PF-06427878 or placebo | EXPERIMENTAL | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo as suspension administered every 8 hours, with food |
| PF-06427878 | DRUG | 500 mg suspension administered every 8 hours, with food |
| [11C]PF-06427878 | DRUG | Single administration via intravenous infusion of 20 ug \[11C\]PF-06427878 on Day 1 of all 3 Periods |
| PF-06427878 10 mg | DRUG | Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration |
| PF-06427878 600 mg | DRUG | Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration |
Inclusion Criteria: * Healthy male and/or female subjects of non childbearing potential. * Body Mass Index (BMI) of \>=25 kg/m2; and a total body weight \>50 kg * Subjects with liver fat \>=6% and \<=20% Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, end...
PF-06427878 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It has been studied in Phase 1 clinical trials involving healthy adult volunteers, including overweight and obese participants. Its therapeutic indication has not been disclosed, and it remains an early-stage research compound rather than an approved medicine.
PF-06427878 is made and developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored all of the Phase 1 studies of the compound, including trials conducted in the United States, Belgium, and the United Kingdom.
PF-06427878 is in Phase 1 clinical development. Five Phase 1 trials have been completed, and none are currently active. The studies enrolled a total of 94 participants and were conducted in healthy volunteers, so the compound is investigational and has not been approved for any use.
PF-06427878 has been evaluated in five completed Phase 1 trials, including NCT02855177, a multiple-dose safety and pharmacokinetic study in overweight and obese healthy subjects; NCT02410525, a positron emission tomography tissue distribution study; NCT02391623, a multiple oral dose study in healthy adults; and NCT02237742, an intravenous dosing study in healthy adult males.
Yes, [11C]PF-06427878 is an alternative name for PF-06427878. The carbon-11 label refers to the radiolabeled form used in a positron emission tomography study, NCT02410525, which characterized tissue distribution of the compound in healthy male volunteers.
PF-06427878 was studied in five completed Phase 1 trials with 94 total participants. The trials were randomized, double-blind, and placebo-controlled, and enrolled healthy volunteers, including overweight and obese subjects. Dosing was tested by both oral and intravenous routes across sites in the United States, Belgium, and the United Kingdom.