None listed
Conditions
Brief summary
CRN00808 is being developed for the treatment of acromegaly. This four-way crossover single dose study will compare the pharmacokinetic and safety profiles of CRN00808 over four periods under the following dosing conditions; Condition A: Subjects will remain fasting for 4 hours after drug administration. Condition B: Subjects will remain fasting for 2 hours after drug administration. Condition C: Subjects will remain fasting for 1 hour after drug administration. Condition D: Subjects will receive a standard dinner then fast for 2 hours prior to drug administration. After dosing, the subject will fast overnight.
Interventions
The intervention for this study, CRN00808, is an orally bioavailable small molecule somatostatin receptor agonist that lowers hormone levels in acromegaly patients. CRN00808 will be administered as a 2 x 10mg capsules for a total dose of 20mg in all four periods.
This study consists of 4 administration conditions:
Condition A: Subjects will remain fasting for 4 hours after drug administration.
Condition B: Subjects will remain fasting for 2 hours after drug administration.
Condition C: Subjects
The intervention for this study, CRN00808, is an orally bioavailable small molecule somatostatin receptor agonist that lowers hormone levels in acromegaly patients. CRN00808 will be administered as a 2 x 10mg capsules for a total dose of 20mg in all four periods. This study consists of 4 administration conditions: Condition A: Subjects will remain fasting for 4 hours after drug administration. Condition B: Subjects will remain fasting for 2 hours after drug administration. Condition C: Subjects will remain fasting for 1 hour after drug administration. Condition D: Subjects will receive a standard dinner then fast for 2 hours prior to drug administration. After dosing, the subject will fast overnight. Subjects will be directly observed by study personnel to ensure that the fasting requirements are adhered to. The Condition D standard dinner will be nutritionally identical for all subjects, however the meal may differ to accommodate subjects with dietary requirements, such as; vegetarian, vegan and gluten free. There will be up to 12 subjects enrolled in this study. All subjects will be administered study drug under each of the four conditions. There will be 8 days between treatment administration for each condition. Subjects will undergo Condition A, B and C in a randomised order. Condition D will be completed by all subjects after completion of Condition A, B and C.
Sponsors
Crinetics Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
- Male and female subjects 18 to 70 years of age - BMI 18 to 30 kg/m2 - 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
- Prior treatment with CRN00808 - Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study. - 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 60 days - Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements - Use of any prior medication without approval of the investigator within 14 days prior to admission - Tested positive 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 Phase 1 study
Outcome results
None listed