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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01091532 | A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects. | PHASE1 | COMPLETED | 48 | — | — | Mar 1, 2010 | Jul 1, 2010 | Dec 4, 2018 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 2 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 3 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 4 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Name | Type | Description |
|---|---|---|
| UK-396,082 | DRUG | 100mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
| placebo | DRUG | given orally twice daily for 14 days |
Inclusion Criteria: * Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Exclusion Criteria: * Evidence ...