Clinical trial NCT06012721: Effect of Food on the Pharmacokinetics of ORIC-114
Official title: A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Effect in Healthy Participants
Keywords: Food effect
ORIC-114
Lead sponsor: ORIC Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
Primary purpose: OTHER

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 14 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: 14 days
measure: Area under the curve (AUC)
timeFrame: 14 days
measure: Apparent plasma terminal elimination half-life (t1/2)
timeFrame: 14 days
Secondary outcomes:
measure: Number of subjects with Treatment Emergent Adverse Effect
timeFrame: 30 days
Other outcomes:
Locations:
city: Geelong
country: Australia
facility: Nucleus Network Pty Ltd., 235 Ryrie St
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd
state: Victoria
Study officials:
affiliation: ORIC Pharmaceuticals
name: Pratik S Multani, MD, MS
role: STUDY_DIRECTOR
References: