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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORIC-101 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIC-101 | Drug | Oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, as assessed by incidence and severity of adverse events. | 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, as assessed by time of observed maximum concentration (Tmax) | 96 hours post-dose | |
| Pharmacokinetics, as assessed by maximum concentration observed (Cmax) | 96 hours post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Miami | Florida | 33126 | United States |
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| Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 to 24 hours post-dose (AUC(0-24)) |
| 96 hours post-dose |
| Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 to last measurable concentration (AUC(0-last)) | 96 hours post-dose |
| Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 extrapolated to infinity (AUC(0-inf)) | 96 hours post-dose |