A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly Treated with Long-acting Somatostatin Receptor Ligands - PATHFNDR-1

Crinetics Pharmaceuticals, Inc.0 个研究点目标入组 52 人开始时间: 2021年5月14日最近更新: 2022年3月2日

研究概览

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•1.Male and female subjects =18 years of age
•2.Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 =1xULN) via stable monotherapy dose of protocol defined somatostatin receptor ligand therapy.
•3.Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control.
•4-Willing to provide signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Treatment naïve acromegaly subjects
•2.Prior treatment with paltusotine.
•3.History of pituitary radiation therapy.
•4.History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
•5.Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer.
•6.Known history of HIV, hepatitis B, or active hepatitis C.
•7.History of alcohol or substance abuse in the past 12 months.
•8.Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
•9.Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
•10.Subjects with symptomatic cholelithiasis.
•11.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
•12.Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)

发起方