Calendario›AMGN›CC-11050

CC-11050

A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole

Ensayo de AMGEN INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

44

previstos

Centros

1

Fin del objetivo primario

feb 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ago 2019.

Qué mide

Adverse Events (AEs) (From enrollment until at least 28 days after completion of study treatment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04139226), actualizada en jun 2020.