Status:
COMPLETED
Effect of Food on the Pharmacokinetics of ORIC-114
Lead Sponsor:
ORIC Pharmaceuticals
Conditions:
Food Effect in Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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
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 ensur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06012721
Start Date
September 11 2023
End Date
November 23 2023
Last Update
January 19 2024
Active Locations (2)
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1
Nucleus Network Pty Ltd., 235 Ryrie St
Geelong, Victoria, Australia, 3220
2
Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd
Melbourne, Victoria, Australia, 3004