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TR-701 FA, vial · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD/ Part A | EXPERIMENTAL | Single IV infusions of placebo or TR-701 FA given at 50, 100, 200, and 400 mg. |
| MAD / Part B | EXPERIMENTAL | Multiple IV infusion of placebo or TR-701 FA given daily for 7 days at 200 and 400 mg. |
| Bioavailability / Part C | EXPERIMENTAL | TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion. |
| Venous Tolerability/ Part D | EXPERIMENTAL | IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days, |
| Name | Type | Description |
|---|---|---|
| TR-701 FA for injection, 200 mg/vial | DRUG | TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 \& 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D |
| TR-701 FA tablets | DRUG | TR-701 FA will be given once orally as a 200 mg tablet in Part C. |
Inclusion Criteria: * in good health * body mass index of 20 to 29.9 kg/m2 * female subjects must be post menopausal for at least 1 year, surgically sterile, abstinent or agree to use an effective method of birth control Exclusion Criteria: * history or clinical manifestation of any clinically si...
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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.