Status:
COMPLETED
Study of ORIC-101 in Healthy Adult Subjects
Lead Sponsor:
ORIC Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential. In this study, ORIC-101 ...
Detailed Description
This is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential. Subjects will receive a single a...
Eligibility Criteria
Inclusion
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 55 years, inclusive
- Weighs more than 50 kilograms (kg), and less than 120 kg, with a body mass index of 18.0 to 32.0 kg/meters squared
Exclusion
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 45 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days
- 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 (female subjects must have a negative pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone \[FSH\] concentration ≥40 international units per litre (IU/L))
- 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 :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03324555
Start Date
October 19 2017
End Date
December 18 2017
Last Update
April 5 2018
Active Locations (1)
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1
Research Center
Miami, Florida, United States, 33126