Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02124213 | A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers | PHASE1 | COMPLETED | 5 | — | — | Sep 1, 2014 | Oct 1, 2014 | Dec 17, 2014 | 1 | Sweden |
| NCT01959594 | A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2013 | Mar 1, 2014 | Mar 28, 2014 | 1 | United States |
| NCT01914796 | A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562 | PHASE1 | COMPLETED | 39 | — | — | Aug 1, 2013 | Dec 1, 2013 | May 23, 2014 | 1 | United States |
Using Positron Emission Tomography and a radiotracer \[11C\]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUC = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - 8).
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Change from baseline cognitive performance
Measurement of eye blink rate for a given dose at time of predicted maximum blood concentration of the compound.
Area under the plasma concentration time-curve from zero to 24 hours
| Arm | Type | Description |
|---|---|---|
| Cohor 1 - 30 mg | EXPERIMENTAL | Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562. |
| Cohort 2 ( adaptive dose, optional) | EXPERIMENTAL | Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1. |
| Cohort 3 ( adaptive dose, optional) | EXPERIMENTAL | Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Optional Cohort 4 | EXPERIMENTAL | - |
| Optional Cohort 5 | EXPERIMENTAL | - |
| Single ascending doses | PLACEBO_COMPARATOR | - |
| Measurement of eye blink rate | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 30 mg PF-06412562 | DRUG | Subject will receive a single dose of 30 mg PF-06412562 |
| PF-06412562 | DRUG | The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional. |
| 3 mg PF-06412562 | DRUG | oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days |
| 10 mg PF-06412562 | DRUG | oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days |
| 25 mg PF-06412562 | DRUG | oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days |
| PF-06412562 TBD mg | DRUG | oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts |
Inclusion Criteria: Healthy Male Volunteers Exclusion Criteria: Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorpti...