Estudio multicéntrico, aleatorizado, controlado, para evaluar la seguridad y eficacia de paltusotine en sujetos con acromegalia no tratada farmacológicamente (PATHFNDR-2)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05192382Tipo: INTERVENTIONALInicio: 17 de dic de 2021Fin estimado: 1 de ene de 2028

Resumen

Estudio aleatorizado, controlado con placebo, diseñado para evaluar la seguridad y eficacia de paltusotine (anteriormente CRN00808; un agonista biased selectivo no peptídico del receptor de somatostatina tipo 2, de administración oral) en sujetos con acromegalia no tratada farmacológicamente.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female subjects ≥18 years of age
Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period.
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

Pituitary radiation therapy within 3 years of Screening
Prior treatment with paltusotine
History of ineffective or intolerance to octreotide or lanreotide
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 or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)

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

Buenos Aires, Argentina

Crinetics Study Site

CABA, Argentina

Crinetics Study Site

CABA, Argentina

Crinetics Study Site

Córdoba, Argentina

Patrocinadores

PrincipalCrinetics Pharmaceuticals Inc.

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