Estudio aleatorizado, controlado, multicéntrico, para evaluar la seguridad y eficacia de paltusotina en sujetos con acromegalia tratados con ligandos del receptor de somatostatina de acción prolongada (PATHFNDR-1)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04837040Tipo: INTERVENTIONALInicio: 12 de may de 2021Fin estimado: 1 de jun de 2027

Resumen

Estudio aleatorizado, controlado con placebo, diseñado para evaluar la seguridad y eficacia de paltusotina (también conocida como CRN00808; un agonista no peptídico de la somatostatina administrado por vía oral) en sujetos con acromegalia tratados previamente con regímenes de tratamiento basados en ligandos del receptor de somatostatina (LRS).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female subjects ≥18 years of age
Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
Willing to provide signed informed consent

Criterios de exclusión

Treatment naïve or treatment-withdrawn acromegaly subjects
Prior treatment with paltusotine
Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
Known history of HIV, hepatitis B, or active hepatitis C
History of alcohol or substance abuse in the past 12 months
Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
Subjects with symptomatic cholelithiasis
Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

Intervenciones

drug

Paltusotine

Paltusotine, tablets, once daily by mouth

drug

Placebo

Placebo, tablets, once daily by mouth

Ubicaciones

Crinetics Study Site

CABA, Buenos Aires, Argentina

Crinetics Study Site

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Crinetics Study Site

Córdoba, Argentina

Patrocinadores

PrincipalCrinetics Pharmaceuticals Inc.

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