Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ORIC-101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen B<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen C<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen D<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen F<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen H<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|
| Experimental: Regimen I<br> | Drug: ORIC-101<br>* Capsule or oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | PK of ORIC-101 as single doses | 96 hours post-final dose | 
| Area under the curve (AUC) | PK of ORIC-101 as single doses | 96 hours post-final dose | 
| Number of participants with adverse events | Safety and tolerability of ORIC-101 as single doses | 96 hours post-final dose | 
| Number of Participants With Abnormal Laboratory Values | Safety and tolerability of ORIC-101 as single doses | 96 hours post-final dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | Comparison of the PK of ORIC-101 in the presence or absence of food | 96 hours post-final dose | 
| Area under the curve (AUC) | Comparison of the PK of ORIC-101 in the presence or absence of food | 96 hours post-final dose | 
| Number of participants with adverse events | Safety and tolerability of ORIC-101 as multiple doses | 96 hours post-final dose | 
| Number of Participants With Abnormal Laboratory Values | Safety and tolerability of ORIC-101 as multiple doses | 96 hours post-final dose | 
| Maximum plasma concentration (Cmax) | PK of ORIC-101 as multiple doses | 96 hours post-final dose | 
| Area under the curve (AUC) | PK of ORIC-101 as multiple doses | 96 hours post-final dose |