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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01452828 | A Pharmacokinetics and Safety Study in Subjects With Renal Impairment | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2011 | Mar 1, 2012 | May 3, 2016 | 2 | United States |
Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Renal Impairment Nondialyzed | EXPERIMENTAL | - |
| Renal Impairment Dialyzed | EXPERIMENTAL | - |
| Matched Control | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TR-701 FA single infusion | DRUG | Single IV infusion, 200 mg daily for 7 days |
| TR-701 FA | DRUG | Two separate infusions of 200 mg |
Inclusion Criteria: * BMI between 18.0 and 40.0 kg/m2 inclusive * Male or female subjects between 18 and 75 years of age * Stable dosage of medication for 30 days * for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months Exclusion Criteria: * Functioning...