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CORT113176

Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants

Ensayo de CORCEPT THERAPEUTICS INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

16

previstos

Centros

1

Fin del objetivo primario

sep 2021

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Number of Participants with One or More Adverse Events (del registro, en inglés) (hasta el dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1 to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176 will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments will include the measurement of serum cortisol.

Más ensayos de CORT

Todos los de CORT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04994743), actualizada en oct 2021.