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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00983255 | Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) | PHASE1 | COMPLETED | 90 | — | — | Sep 1, 2009 | Jan 1, 2010 | May 19, 2016 | 1 | United States |
| 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...