Effect of Food on the Pharmacokinetics of ORIC-114

Food Effect in Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06012721
• Other study ID #: ORIC-114-03
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2023
• Est. completion date: November 23, 2023

Study information

• Verified date: January 2024
• Source: ORIC Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Effect in Healthy Participants

Intervention

Drug:
• ORIC-114
Food effect healthy subjects

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd., 235 Ryrie St	Geelong	Victoria
Australia	Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
ORIC Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)	To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation	14 days
Primary	Time of maximum observed concentration (Tmax)	Food Effect: PK of ORIC-114 tablet	14 days
Primary	Area under the curve (AUC)	Food Effect: PK of ORIC-114 tablet	14 days
Primary	Apparent plasma terminal elimination half-life (t1/2)	Food Effect: PK of ORIC-114 tablet	14 days
Secondary	Number of subjects with Treatment Emergent Adverse Effect	Assessed by NCI CTCAE v5.0	30 days