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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01074710 | Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers | PHASE1 | COMPLETED | 8 | — | — | Feb 1, 2010 | May 1, 2010 | Jul 19, 2010 | 1 | United States |
Pharmacokinetic endpoints will include apparent clearance (CL/F), AUCt, AUC∞, Cmax, tmax, and t1/2,Z for 13C-uracil and its metabolites. The PK linearity and correlation between plasma concentration and urine excretion will be evaluated. Expired 13CO2 concentrations (Δ13C) will be converted to 13CO2-excretion(% dose/hr) to assess breath PK parameters (AUCt, AUC∞, Cmax, tmax, λZ, and t1/2,Z).
| Arm | Type | Description |
|---|---|---|
| C13-URA | EXPERIMENTAL | administered C13-URA 50, 100, 200mg in same subjects |
| Placebo | PLACEBO_COMPARATOR | 2 same subjects |
| Name | Type | Description |
|---|---|---|
| [2-13C] uracil | DRUG | po, in the form of semi-solid meal, granules, once a period |
| [2-13C] uracil, placebo | DRUG | po, in the form of semi-solid meal, granules, once a period |
Inclusion Criteria: * Body mass index \[range is 18.5 to 29.9 kg/m2\] * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs Exclusion Criteria: * Significant history or clinical manifestation of any significant ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |