Study of ORIC-101 in Healthy Adult Subjects
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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 will be administered as single-ascending oral doses. The primary objective is to characterize the safety and tolerability of oral ORIC-101.
Key facts
- Study ID
- NCT03324555
- Run by
- ORIC Pharmaceuticals
- People needed
- 24
- Starts
- 2017-10-19
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2018-04-05
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Center — Miami, Florida, United States
Full record on ClinicalTrials.gov
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