Effect of Food on the Pharmacokinetics of ORIC-114

NCT06012721 | Completed Phase 1

• 1 other identifier: ORIC-114-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Effect in Healthy Participants

Keywords

Food effect; ORIC-114

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of subjects with Treatment Emergent Adverse Effect

  30 days

Study Arms (4)

Part 1 Treatment A

EXPERIMENTAL

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

Drug: ORIC-114

Part 1 Treatment B

EXPERIMENTAL

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

Part 2 Treatment A

EXPERIMENTAL

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

Drug: ORIC-114

Part 2 Treatment B

EXPERIMENTAL

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

Interventions

ORIC-114 DRUG

Food effect healthy subjects

Part 1 Treatment A; Part 1 Treatment B; Part 2 Treatment A; Part 2 Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ORIC Pharmaceuticals: lead

Study Sites (2)

Nucleus Network Pty Ltd., 235 Ryrie St

Geelong, Victoria, 3220, Australia

Location

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

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Pratik S Multani, MD, MS

  ORIC Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, 2-part, 2-sequence, 2-period, open-label, crossover

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 25, 2023
• Study Start: September 11, 2023
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)