Brief Title
An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Official Title
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)
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level
Secondary Outcome
Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN)
Condition
Acromegaly
Intervention
Paltusotine
Study Arms / Comparison Groups
Paltusotine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
45
Start Date
January 15, 2019
Completion Date
September 2020
Primary Completion Date
August 2020
Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects 18 to 70 years of age
2. Confirmed diagnosis of acromegaly with either a partial or complete response to
protocol defined somatostatin analogue therapy regimens
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
Exclusion Criteria:
1. Treatment naïve acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation
therapy may be eligible with some restrictions.
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. 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
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,
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
12. 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
13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than
every 4 weeks (e.g. every 6 weeks or 8 weeks)
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03789656
Organization ID
CRN00808-03
Secondary IDs
2018-002230-20
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
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Verification Date
May 2020