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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01119235 | A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers. | PHASE1 | COMPLETED | 24 | — | — | May 1, 2010 | Jul 1, 2010 | Aug 6, 2010 | 1 | Belgium |
| NCT01103739 | To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications | PHASE1 | COMPLETED | 24 | — | — | Mar 1, 2010 | May 1, 2010 | Jun 4, 2010 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: PF-04531083 | ACTIVE_COMPARATOR | - |
| Cohort 2: PF-04531083 | ACTIVE_COMPARATOR | - |
| cohort 1 | EXPERIMENTAL | - |
| cohort 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04531083 | DRUG | Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days |
| simvastatin | DRUG | Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. |
Inclusion Criteria: * Young * Healthy volunteers Exclusion Criteria: * Elderly volunteers * Patients with any existing medical conditions considered likely to impinge on study execution