Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

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 drug-drug interaction phase (one cohort of 8 subjects).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Crinetics Pharmaceuticals Inc.
• Treatments: Midazolam; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• BMI 18 to 30 kg/m2

• Females postmenopausal or surgically sterile

Exclusion Criteria:

• 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