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PCS499
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
Ensayo de Processa Pharmaceuticals, Inc. en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 18
- Centros
- 1
- Fin del objetivo primario
- jun 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2018.
Qué mide
Maximum plasma concentrations (Cmax) for Part 1 (Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.
Más ensayos de PCSA
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| PCS6422 and capecitabine | Fase 2 | Reclutando pacientes | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| PCS6422 and capecitabine | Fase 1 | Completado | jun 2024 (real) |
| PCS499 | Fase 2 | Interrumpido | feb 2023 (real) |
| PCS12852 · MOMENTUM | Fase 2 | Completado | sep 2022 (real) |
| PCS499 | Fase 2 | Completado | feb 2020 (real) |
| RX-3117 | Fase 1/2 | Completado | oct 2019 (real) |
Todos los de PCSA, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03836222), actualizada en feb 2019.