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CORT125236

Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants

Ensayo de CORCEPT THERAPEUTICS INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

82

previstos

Centros

1

Fin del objetivo primario

feb 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ago 2021.

Qué mide

Number of Participants with One or More Adverse Events (Part 1 SAD Cohorts: up to Day 12; Part 2 MAD Cohorts: up to Day 25; Part 3 Cohort: up to Day 19) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.

Más ensayos de CORT

Todos los de CORT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05003713), actualizada en mar 2023.