Acromegaly MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: CRN00808
Product Code: CRN00808
Pharmaceutical Form: Capsule
INN or Proposed INN: not assigned yet
Current Sponsor code: CRN00808
Other descriptive name: CRN00808.HCl
Concentration unit:
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 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 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 3
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 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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To evaluate the efficacy of CRN00808 in acromegaly subjects treated with somatostatin analogue based treatment regimens; 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): Change from baseline (mean of Screening values) in IGF-1 level at W13;Timepoint(s) of evaluation of this end point: 13 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Proportion of subjects with the mean of their last two consecutive IGF-1 measurements =ULN; 2.Proportion of subjects with the mean of their last two consecutive IGF-1 measurements =1.5×ULN; 3.Proportion of subjects who achieve serum GH <5.0 ng/mL at W13. ;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