Status:
COMPLETED
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Lead Sponsor:
Crinetics Pharmaceuticals Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam ...
Detailed Description
The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog ...
Eligibility Criteria
Inclusion
- BMI 18 to 30 kg/m2
- Females postmenopausal or surgically sterile
Exclusion
- Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
- History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
- Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
- 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 6 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03276858
Start Date
September 22 2017
End Date
April 30 2018
Last Update
August 29 2018
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia