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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01294566 | FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers | PHASE1 | COMPLETED | 17 | — | — | Nov 29, 2010 | Mar 23, 2011 | Jun 28, 2017 | 1 | Australia |
includes abnormal clincal lab values, ECGs, vital signs
includes AUC, Cmax, tmax, and t1/2
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | GSK1322888 (1 mg, 2 mg, 5 mg, 10 mg; 6 subjects) and Placebo (32 subjects) |
| Cohort 2 | EXPERIMENTAL | GSK1322888 (20 mg, 40 mg, 80 mg, and dose to be determined; 6 subjects) and Placebot (2 subjects) |
| Name | Type | Description |
|---|---|---|
| GSK1322888 | DRUG | 1 mg, 5 mg or 25 mg capsule |
| Placebo | DRUG | matching placebo capsules |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \< or =1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician * Male or female between 18 (20 for Japanese) an...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |