Study of ORIC-101 in Healthy Adult Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/17/2018 |
Start Date: | October 19, 2017 |
End Date: | December 18, 2017 |
A Phase 1 Single-ascending Dose Study of the Oral Glucocorticoid Receptor Antagonist ORIC-101 in Healthy Adult Subjects
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.
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.
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 administration of ORIC-101 oral suspension on a single
occasion and will be followed in the clinic for at least 96 hours post-dose. Total subject
participation will be approximately 5 weeks from screening until discharge from the study.
The primary objective of the study is to characterize the safety and tolerability of oral
ORIC-101 administered as a single dose in adult healthy subjects. The secondary objective of
the study is to evaluate the pharmacokinetics of ORIC-101 and its metabolites M1 and M2. The
exploratory objective of the study is to assess the pharmacodynamics of ORIC-101 by
measurement of serum and urine levels of cortisol and other biological markers in healthy
subjects
male subjects and healthy female subjects of non-child bearing potential.
Subjects will receive a single administration of ORIC-101 oral suspension on a single
occasion and will be followed in the clinic for at least 96 hours post-dose. Total subject
participation will be approximately 5 weeks from screening until discharge from the study.
The primary objective of the study is to characterize the safety and tolerability of oral
ORIC-101 administered as a single dose in adult healthy subjects. The secondary objective of
the study is to evaluate the pharmacokinetics of ORIC-101 and its metabolites M1 and M2. The
exploratory objective of the study is to assess the pharmacodynamics of ORIC-101 by
measurement of serum and urine levels of cortisol and other biological markers in healthy
subjects
Inclusion Criteria:
1. Healthy males or healthy females of non-child bearing potential
2. Age 18 to 55 years, inclusive
3. 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 Criteria:
1. 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
2. History of any drug or alcohol abuse in the past 2 years
3. Current smokers and those who have smoked within the last 12 months
4. 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))
5. Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with
atypia or endometrial carcinoma
6. Current disease requiring treatment with systemic corticosteroids.
7. Serious adverse reaction or serious hypersensitivity to mifepristone, or any other
drug, or the formulation excipients
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