Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly

Phase 1

• Conditions: Acromegaly; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-005431-70-HU
• Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1.Male and female subjects =18 years of age
2.Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 =1.0×ULN) via stable monotherapy dose of protocol defined somatostatin receptor ligand therapy. (Upper limit of eligibility is mean IGF-1 of 1.04 rounded to 2 decimal places.)
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

Exclusion Criteria

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.Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
9.Subjects with symptomatic cholelithiasis.
10.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
11.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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified