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CORT113176 Lipid Capsule…

Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

Ensayo de CORCEPT THERAPEUTICS INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

110

previstos

Centros

1

Fin del objetivo primario

oct 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ene 2020.

Qué mide

Number of Participants with One or More Adverse Events (Part 1 SAD Cohorts: up to Day 9; Part 2 MAD Cohorts: up to Day 23; 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 CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 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 pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.

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Todos los de CORT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04249323), actualizada en ene 2022.