Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06751979 · 1 trial · 1 indication
the plasma midazolam AUC from 0 to tlast (time of last quantifiable concentration) when a single oral midazolam dose given alone
the midazolam Cmax when single oral midazolam dose given alone
the plasma midazolam AUC from 0 to infinity when a single oral midazolam dose given alone
the plasma midazolam AUC from 0 to tlast (time of the last quantifiable concentration) when a single oral midazolam given in presence of steady state PF-06751979
the midazolam Cmax when a single oral midazolam given in presence of steady state PF-06751979
the plasma midazolam AUC from 0 to infinity when a single oral midazolam given in presence of steady state PF-06751979
| Arm | Type | Description |
|---|---|---|
| oral midazolam alone | EXPERIMENTAL | single dose of oral midazolam administered alone in period 1 |
| oral midazolam administered with multiple doses of PF-06751979 | EXPERIMENTAL | single dose of midazolam on day 10 with multiple doses of PF-06751979 once a day on Days 1-11 in period 2 |
| Name | Type | Description |
|---|---|---|
| midazolam | DRUG | a single oral dose of 2 mg midazolam |
| PF-06751979 | DRUG | multiple oral doses of PF-06751979 100 mg a day |
Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examinat...
PF-06751979 is an investigational small molecule being studied in healthy subjects and healthy elderly volunteers. It is being evaluated for safety, tolerability, and blood concentration after single and multiple escalating oral doses. It is not approved for any indication and remains in clinical development.
PF-06751979 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.
PF-06751979 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
PF-06751979 has been studied in two completed Phase 1 trials. NCT02793232 evaluated safety, tolerability, and blood concentration after single and multiple escalating oral doses in healthy and elderly volunteers. NCT03126721 evaluated the effect of multiple doses on the pharmacokinetics of midazolam in healthy adults.
The mechanism of action for PF-06751979 has not been disclosed in the available information. It is a small molecule being studied for its safety and pharmacokinetic profile in healthy subjects, but its molecular target is not specified.