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A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult subjects.
The study will be performed in two parts. Part 1 will assess the effect of food at a lower dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure as a way to ensure the safety of the participating subjects. Part 2 will further assess the food effect at a higher dose of ORIC-114.
If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be conducted upon assessment by the Sponsor.
If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated efficacious clinical dose range based on results from Part 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Treatment A | Experimental | 30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
|
| Part 1 Treatment B | Experimental | 30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. |
|
| Part 2 Treatment A | Experimental | xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
|
| Part 2 Treatment B | Experimental | xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIC-114 | Drug | Food effect healthy subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation | 14 days |
| Time of maximum observed concentration (Tmax) | Food Effect: PK of ORIC-114 tablet | 14 days |
| Area under the curve (AUC) | Food Effect: PK of ORIC-114 tablet | 14 days |
| Apparent plasma terminal elimination half-life (t1/2) | Food Effect: PK of ORIC-114 tablet | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Treatment Emergent Adverse Effect | Assessed by NCI CTCAE v5.0 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratik S Multani, MD, MS | ORIC Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd., 235 Ryrie St | Geelong | Victoria | 3220 | Australia | ||
| Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd |
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Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
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| Melbourne |
| Victoria |
| 3004 |
| Australia |