Status:
COMPLETED
Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects
Lead Sponsor:
ORIC Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagoni...
Eligibility Criteria
Inclusion
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m\^2 and weight between 50 kg and 120 kg, inclusive
Exclusion
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Current smokers and those who have smoked within the last 12 months
- Females of childbearing potential
- Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
- Current disease requiring treatment with systemic corticosteroids
- Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03835637
Start Date
March 23 2018
End Date
July 4 2018
Last Update
February 8 2019
Active Locations (1)
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1
Research Center
Nottingham, United Kingdom