Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TR-701 FA single infusion · 1 trial · 1 indication
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...
TR-701 FA single infusion is an investigational small molecule being studied for use in patients with renal impairment. It is in Phase 1 clinical development for this condition, with a completed pharmacokinetics and safety study evaluating its effects in this patient population.
TR-701 FA single infusion is being developed by Merck & Company, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for renal impairment.
TR-701 FA single infusion is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for use in patients with renal impairment. One Phase 1 clinical trial has been completed for this indication.
TR-701 FA single infusion has one completed clinical trial, NCT01452828, titled "A Pharmacokinetics and Safety Study in Subjects With Renal Impairment." This Phase 1 study enrolled 24 participants in the United States and evaluated the drug's pharmacokinetics and safety in patients with renal impairment.
TR-701 FA single infusion is a formulation of TR-701, specifically designed for single intravenous infusion. The drug is being developed by Merck & Company, Inc. for renal impairment and is currently in Phase 1 clinical development.