Effect of Food on the Pharmacokinetics of ORIC-114

Sponsor

ORIC Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06012721

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Food Effect in Healthy Participants	Drug: ORIC-114	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, 2-part, 2-sequence, 2-period, open-label, crossoverRandomized, 2-part, 2-sequence, 2-period, open-label, crossover

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) [14 days]
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
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
Apparent plasma terminal elimination half-life (t1/2) [14 days]
Food Effect: PK of ORIC-114 tablet

Secondary Outcome Measures

Number of subjects with Treatment Emergent Adverse Effect [30 days]
Assessed by NCI CTCAE v5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network Pty Ltd., 235 Ryrie St	Geelong	Victoria	Australia	3220
2	Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

ORIC Pharmaceuticals

Investigators

Study Director: Pratik S Multani, MD, MS, ORIC Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ORIC Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT06012721

Other Study ID Numbers:

ORIC-114-03

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by ORIC Pharmaceuticals

Food effect

ORIC-114

Study Results

No Results Posted as of Aug 25, 2023