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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02521389 | Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143 | PHASE1 | COMPLETED | 35 | — | — | Jun 29, 2015 | Feb 24, 2017 | Aug 29, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | 3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required. |
| Part 2 | EXPERIMENTAL | Single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects. |
| Name | Type | Description |
|---|---|---|
| PWT-143 | DRUG | phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor |
Inclusion Criteria: 1. Healthy males 2. Age 18 to 65 years of age 3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator 4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no condi...