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TR-701 · 3 trials · 4 indications
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
| Arm | Type | Description |
|---|---|---|
| TR-701 200 mg | EXPERIMENTAL | - |
| TR-701 300 mg | EXPERIMENTAL | - |
| TR-701 400 mg | EXPERIMENTAL | - |
| after fast | EXPERIMENTAL | Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state. |
| After high fat food | EXPERIMENTAL | Administration of a single oral dose of 600mg TR-701 to subjects in the fed state. |
| 1 | EXPERIMENTAL | Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg. |
| 2 | PLACEBO_COMPARATOR | Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10. |
| 3 | ACTIVE_COMPARATOR | Oral doses of 600mg linezolid given twice daily for 21 days. |
| Name | Type | Description |
|---|---|---|
| TR-701 200 mg | DRUG | oral TR-701 200 mg for 5 to 7 days |
| TR-701 300 mg | DRUG | oral TR-701 300 mg for 5 to 7 days |
| TR-701 400 mg | DRUG | TR-701 400 mg for 5 to 7 days |
| TR-701 600mg | DRUG | TR-701 600mg |
| TR-701 | DRUG | TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8. |
| linezolid | DRUG | Linezolid will be given at 600 mg twice daily for 21 days in cohort 10. |
| placebo | DRUG | Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10. |
Inclusion Criteria: * Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms * Suspected or confirmed infection due to a gram-positive organism Exclusion Criteria: * Complicated skin and skin structure infection due to gram-negative organisms * Complicated...
TR-701 is an investigational small molecule being studied for use in healthy subjects and in patients with complicated skin and skin structure infections, including bacterial skin diseases. It is not approved and remains in clinical development.
TR-701 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK.
TR-701 is in Phase 1 clinical development. It has completed Phase 1 trials in healthy adults and a Phase 2 trial in patients with complicated skin and skin structure infections, but it is not approved.
TR-701 has completed three clinical trials: NCT00671359, a food effects study of a single 600 mg oral dose in healthy subjects; NCT00671814, a single and multiple ascending dose pharmacokinetic study in healthy adults; and NCT00761215, a Phase 2 study in patients with complicated skin and skin structure infections.
TR-701 and TR701 refer to the same investigational drug. The name appears with and without a hyphen in clinical trial records, such as NCT00671814, which uses TR701, and NCT00761215, which uses TR-701.