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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02373072 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease | PHASE1 | COMPLETED | 18 | — | — | Mar 1, 2015 | Mar 1, 2016 | Sep 22, 2023 | 8 | United States, Belgium |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. |
| Cohort 2 | EXPERIMENTAL | Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. |
| Name | Type | Description |
|---|---|---|
| PF-06649751 | DRUG | Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg. |
| Trimethobenzamide Hydrochloride | DRUG | 300mg TID, Capsules. Optional in both Cohorts. |
| Placebo | DRUG | Subjects completing all three treatment periods will be receiving placebo once. |
Inclusion Criteria: * L-DOPA-responsiveness * Hoehn \& Yahr Stage II-III inclusive * Experiencing motor fluctuations * Stable daily dose of L-DOPA of at least 300 mg * Females on non-childbearing potential and male subjects Exclusion Criteria: * History of troublesome dyskinesias * History of sur...