Calendario›GRCE›GTX-104
GTX-104
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
Ensayo de Grace Therapeutics, Inc. en Aneurysmal Subarachnoid Hemorrhage (del registro, en inglés).
Lo que ha anunciado la empresa
La empresa anunció que alcanzó su objetivo principal…one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored…
En un 8-K del 28 jul 2026, en una frase que nombra «GTX-104». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored…
En un 8-K del 18 jun 2026, en una frase que nombra «GTX-104». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…challenges and potentially displace oral as SoC Nimodipine is the SoC and clinically de-risked; however, significant unmet needs remain with available oral formulations Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical evidence of GTx-104 benefit vs oral capsules 3 Executive Summary aSAH: aneurysmal Subarachnoid Hemorrhage. All dates based on calendar year in the presentation. GTx-104 | aSAH Potential to address…
En un 8-K del 18 jun 2026, en una frase que nombra «GTX-104». El documento en la SEC.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 58
- Centros
- 1
- Fin del objetivo primario
- feb 2022
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2021.
Qué mide
Cmax Day 1 (Day 1 for the first dose (8:00 AM dose)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).
Más ensayos de GRCE
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| GTX-104 · STRIVE-ON | Fase 3 | En marcha, sin reclutar | dic 2024 (prevista, ya pasada: sin actualizar en el registro) |
| GTX-102 medium dose fast Period… | Fase 1 | Sin noticias del promotor | nov 2022 (real) |
| GTX-101 | Fase 1 | Sin noticias del promotor | ago 2022 (real) |
| CaPre · TRILOGY 2 | Fase 3 | Completado | sep 2019 (real) |
| CaPre · TRILOGY 1 | Fase 3 | Completado | jul 2019 (real) |
| CaPre · TRIFECTA | Fase 2 | Completado | jun 2014 (real) |
Todos los de GRCE, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05418348), actualizada en ago 2023.