Effect of Food on the Pharmacokinetics of ORIC-114

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in Healthy Subjects

Conditions
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Food Effect in Healthy Participants

Intervention / Treatment
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* Drug: ORIC-114


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee Able to swallow multiple tablets. Exclusion Criteria: Mentally or legally incapacitated or has significant emotional problems History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. History or presence of clinically significant GI disorder ( Female subjects of childbearing potential. Positive urine drug screen or alcohol breath test results Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) Lactose intolerant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Treatment A<br>30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. | Drug: ORIC-114<br>* Food effect healthy subjects<br>|
| Experimental: Part 1 Treatment B<br>30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. | Drug: ORIC-114<br>* Food effect healthy subjects<br>|
| Experimental: Part 2 Treatment A<br>xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. | Drug: ORIC-114<br>* Food effect healthy subjects<br>|
| Experimental: Part 2 Treatment B<br>xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. | Drug: ORIC-114<br>* Food effect healthy subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Treatment Emergent Adverse Effect | Assessed by NCI CTCAE v5.0 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect, ORIC-114