Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TR-701 FA · 9 trials · 5 indications
Responder: No increase in lesion surface area from baseline.
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
The primary objective is to determine the safety of oral 200 mg TR-701 free acid (FA) administered once daily for 10 days in healthy adults. Safety outcome measures include the number and proportion of participants with adverse events, changes in vital signs and ECG, and evaluation of physical examination changes including neurologic and ophthalmologic exams.
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.
Pharmacokinetic parameters compared with baseline measurements.
To describe the single-dose pharmacokinetics (PK) of IV and oral TR-701 FA administration in 12 to 17 year old adolescent patients, based on the individual plasma and urine concentration-time data.
| Arm | Type | Description |
|---|---|---|
| TR-701 FA | EXPERIMENTAL | • TR-701 FA IV followed by TR-701 FA tablets |
| Linezolid | ACTIVE_COMPARATOR | • Linezolid IV followed by Linezolid Tablets |
| TR-701 FA with PSE | EXPERIMENTAL | TR-701 FA 200 mg oral with PSE |
| TR-701 FA Placebo with PSE | PLACEBO_COMPARATOR | TR-701 FA Placebo 200 mg oral with PSE |
| Elderly subjects (65 or older) | EXPERIMENTAL | - |
| Younger adults (18-45 years old) | EXPERIMENTAL | - |
| Moxifloxacin 400 mg | ACTIVE_COMPARATOR | - |
| TR-701 FA 1200 mg | EXPERIMENTAL | - |
| TR-701 FA 200 mg plus Placebo | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Moderate hepatic | EXPERIMENTAL | - |
| Severe Hepatic | EXPERIMENTAL | - |
| Matched control | EXPERIMENTAL | - |
| healthy volunteer | EXPERIMENTAL | healthy volunteers |
| oral TR-701 FA | EXPERIMENTAL | Single oral dose of 200 mg TR-701 |
| IV TR-701 FA | EXPERIMENTAL | Single IV infusion of 200 mg TR-701 FA |
| Name | Type | Description |
|---|---|---|
| TR-701 FA | DRUG | * TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion * TR-701 FA Tablets, 200 mg, orally once daily |
| Linezolid | DRUG | * Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion * Linezolid Tablets, 600 mg, orally every 12 hours |
| TR-701 FA with PSE | DRUG | TR-701 FA Oral 200 mg oral with PSE |
| TR-701 FA Placebo with PSE | OTHER | TR-701 FA Placebo Oral 200 mg with PSE |
| TR-701 FA 200 mg | DRUG | Single oral tablet of TR-701 FA to elderly subjects |
| TR-701 FA 1200 mg | DRUG | 6 tablet of T-701 FA |
| Moxifloxacin 400 mg | DRUG | 1 tablet 400 mg Moxifloxacin |
| TR-701 FA 200 mg plus Placebo | DRUG | 1 tablet of TR-701 FA with 5 tablet placebo |
| Placebo | DRUG | 6 placebo tablets |
Inclusion Criteria: * Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI. * Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections Exclusion Criteria: * Uncomplicated skin infections * Severe sepsis or septic shock * AB...
TR-701 FA is an investigational small molecule being studied for bacterial infections, including skin and subcutaneous tissue bacterial infections such as major cutaneous abscess, cellulitis, and erysipelas. It has also been evaluated in healthy volunteers and in subjects with hepatic impairment.
TR-701 FA is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials of the drug in the United States.
TR-701 FA is in Phase 1 clinical development. It has completed Phase 1 trials, and one Phase 2 trial has also been completed. The drug remains investigational and is not yet approved for any use.
TR-701 FA has completed several clinical trials, including NCT00983255, a Phase 1 ascending dose pharmacokinetic and absolute bioavailability study in bacterial infections; NCT01461460, a thorough QT study in healthy subjects; NCT01496677, a pharmacokinetics, safety, and tolerability study in elderly subjects; and NCT01519778, a Phase 2 safety and exploratory skin lesion measurement study.
Yes, TR-701 FA stands for TR-701 free acid. Clinical trial titles refer to TR-701 free acid (FA), and the drug is identified by the same name across studies. It is an investigational small molecule being studied for bacterial infections.