Calendario›CORT›Relacorilant 350mg

Relacorilant 350mg

Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Ensayo de CORCEPT THERAPEUTICS INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

52

previstos

Centros

1

Fin del objetivo primario

jul 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2018.

Qué mide

Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) (predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.

Más ensayos de CORT

Todos los de CORT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03512548), actualizada en mar 2020.