Effect of Food on the Pharmacokinetics of ORIC-114

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

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.

Study Overview

• Status: Completed
• Conditions: Food Effect in Healthy Participants
• Intervention / Treatment: Drug: ORIC-114

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Nucleus Network Pty Ltd., 235 Ryrie St
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Treatment A; 30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.	Drug: ORIC-114; Food effect healthy subjects
Experimental: Part 1 Treatment B; 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; Food effect healthy subjects
Experimental: Part 2 Treatment A; xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.	Drug: ORIC-114; Food effect healthy subjects
Experimental: Part 2 Treatment B; 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; Food effect healthy subjects

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ORIC Pharmaceuticals
• Investigators: Study Director: Pratik S Multani, MD, MS, ORIC Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Food effect; ORIC-114
• Other Study ID Numbers: ORIC-114-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No