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

ORIC-114-03

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.

2023-09-11

2023-11-23

2023-11-23

Completed

Early phase I

32

Inclusion Criteria: 1. Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age 2. Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days 3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee 5. Able to swallow multiple tablets. Exclusion Criteria: 1. Mentally or legally incapacitated or has significant emotional problems 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. 4. History or presence of clinically significant GI disorder ( 5. Female subjects of childbearing potential. 6. Positive urine drug screen or alcohol breath test results 7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) 8. Lactose intolerant.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, 2-part, 2-sequence, 2-period, open-label, crossover', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2024-01-19