Effect of Food on the Pharmacokinetics of ORIC-114

Phase 1

Completed

• Conditions: Food Effect in Healthy Participants
• Interventions: Drug: ORIC-114

• Registration Number: NCT06012721
• Lead Sponsor: ORIC Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-25
• Study Start: 2023-09-11
• Primary Completion: 2023-11-23
• Study Completion: 2023-11-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2 Treatment B	ORIC-114	xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
Part 1 Treatment A	ORIC-114	30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
Part 1 Treatment B	ORIC-114	30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
Part 2 Treatment A	ORIC-114	xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	14 days	To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Apparent plasma terminal elimination half-life (t1/2)	14 days	Food Effect: PK of ORIC-114 tablet
Time of maximum observed concentration (Tmax)	14 days	Food Effect: PK of ORIC-114 tablet
Area under the curve (AUC)	14 days	Food Effect: PK of ORIC-114 tablet

Secondary Outcome Measures

Name	Time	Method
Number of subjects with Treatment Emergent Adverse Effect	30 days	Assessed by NCI CTCAE v5.0

Trial Locations

Locations (2)

Nucleus Network Pty Ltd., 235 Ryrie St; 🇦🇺 Geelong, Victoria, Australia

Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd; 🇦🇺 Melbourne, Victoria, Australia