Effect of Food on the Pharmacokinetics of ORIC-114

NCT ID: NCT06012721

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2023-11-23

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.

Conditions

Food Effect in Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1 Treatment A

30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.

Group Type: EXPERIMENTAL

ORIC-114

Intervention Type: DRUG

Food effect healthy subjects

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.

Group Type: EXPERIMENTAL

ORIC-114

Intervention Type: DRUG

Food effect healthy subjects

Part 2 Treatment A

xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.

Group Type: EXPERIMENTAL

ORIC-114

Intervention Type: DRUG

Food effect healthy subjects

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.

Group Type: EXPERIMENTAL

ORIC-114

Intervention Type: DRUG

Food effect healthy subjects

Interventions

ORIC-114

Food effect healthy subjects

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ORIC Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratik S Multani, MD, MS

Role: STUDY_DIRECTOR

ORIC Pharmaceuticals

Locations

Nucleus Network Pty Ltd., 235 Ryrie St

Geelong, Victoria, Australia

Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

ORIC-114-03

Identifier Type: -

Identifier Source: org_study_id