Acromegaly MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Crinetics Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female subjects 18 to 70 years of age; 2.Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot 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 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Treatment naïve acromegaly subjects 2.Prior treatment with CRN00808 3.Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry; 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 mediations 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 who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months); 13.Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg; 14.Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To determine the efficacy of CRN00808 in acromegaly subjects that are complete responders to parenteral octreotide LAR or lanreotide depot monotherapy; 2.To evaluate the safety and tolerability of CRN00808 in acromegaly subjects; 3.To evaluate the pharmacokinetics (PK) of CRN00808 in acromegaly subjects. ;Secondary Objective: NA;Primary end point(s): Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements =ULN);Timepoint(s) of evaluation of this end point: Week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Proportion of subjects who achieve serum GH <5.0 ng/mL ; 2.Change in IGF-1 levels; 3.Change in GH levels; 4.Change in symptoms of acromegaly. ;Timepoint(s) of evaluation of this end point: Week 13 | — |
Countries
Germany, Greece, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Slovakia, United Kingdom, United States
Contacts
Public Contactregulatory unit
Accelsiors CRO and Consultancy Services Ltd.
Outcome results
None listed