Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy volunteers, healthy subjects, and healthy adult males. It has been evaluated in Phase 1 clinical trials to understand how the body reacts to the drug when given intravenously or orally, including its safety, tolerability, and pharmacokinetics.
PF-06427878 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored multiple Phase 1 clinical trials of this investigational drug in healthy volunteer populations.
PF-06427878 is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. All completed trials for PF-06427878 are Phase 1 studies, indicating it is still in early-stage clinical research.
PF-06427878 has been studied in four completed Phase 1 clinical trials: NCT02237742, NCT02391623, NCT02410525, and NCT02855177. These trials evaluated the drug's safety, tolerability, and pharmacokinetics in healthy subjects, including studies with intravenous and oral administration, as well as a positron emission tomography imaging study.
No alternative names for PF-06427878 have been identified in the available clinical trial information. The drug is referred to solely by its code name PF-06427878 in the registered trials, and no other names or aliases are associated with it.