An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Study Overview
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Brief Summary
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An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

Official Title
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An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Paltusotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 18 to 70 years of age Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens 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 Exclusion Criteria: Treatment naïve acromegaly subjects Prior treatment with paltusotine Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions. 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 Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result 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, and 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 taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paltusotine<br> | Drug: Paltusotine<br>* Paltusotine, capsules, once daily by mouth<br>* Other names: CRN00808;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level |  | 13 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) |  | 13 Weeks | 
| Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN |  | 13 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EDGE, Acromegaly, ACROBAT, Paltusotine