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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00666601 | Microdialysis and Pharmacokinetic Study of TR-701 | PHASE1 | COMPLETED | 15 | — | — | Apr 4, 2008 | Aug 12, 2008 | Nov 15, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Pilot study | EXPERIMENTAL | 3 subjects, open lable, microdialysis single dose. |
| Main Study | EXPERIMENTAL | 12 subjects, open label, single dose of 600 mg. |
| Name | Type | Description |
|---|---|---|
| TR-700 (active moiety) | DRUG | A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of approximately 2 µg/mL at a flow rate of 1.5 µL/min for 60 minutes for a total maximum dose of 0.36 µg (0.18 µg per probe). |
| TR-701 (pro-drug) | DRUG | Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701 |
Inclusion Criteria: * Body mass index of 20 to 29 kg/m2 * Agree not to consume any products containing tobacco, alcohol, quinine, grapefruit, caffeine, or high levels of tyramine * Agree not to use any other medication * Female subjects must be postmenopausal (for at least 6 months), surgically ste...