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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental |
| |
| Regimen B | Experimental |
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| Regimen C | Experimental |
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| Regimen D | Experimental |
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| Regimen F | Experimental |
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| Regimen H | Experimental |
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| Regimen I | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIC-101 | Drug | Capsule or oral suspension |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Nottingham | United Kingdom |
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| 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 |