Healthy Volunteers
Conditions
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 antagonist ORIC-101.
Interventions
DRUGORIC-101
Capsule or oral suspension
Sponsors
ORIC Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | 96 hours post-final dose | Safety and tolerability of ORIC-101 as single doses |
| Maximum plasma concentration (Cmax) | 96 hours post-final dose | PK of ORIC-101 as single doses |
| Area under the curve (AUC) | 96 hours post-final dose | PK of ORIC-101 as single doses |
| Number of participants with adverse events | 96 hours post-final dose | Safety and tolerability of ORIC-101 as single doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | 96 hours post-final dose | Comparison of the PK of ORIC-101 in the presence or absence of food |
| Area under the curve (AUC) | 96 hours post-final dose | Comparison of the PK of ORIC-101 in the presence or absence of food |
| Number of participants with adverse events | 96 hours post-final dose | Safety and tolerability of ORIC-101 as multiple doses |
| Number of Participants With Abnormal Laboratory Values | 96 hours post-final dose | Safety and tolerability of ORIC-101 as multiple doses |
Countries
United Kingdom
Outcome results
None listed