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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06012721




Registration number
NCT06012721
Ethics application status
Date submitted
17/08/2023
Date registered
25/08/2023
Date last updated
19/01/2024

Titles & IDs
Public title
Effect of Food on the Pharmacokinetics of ORIC-114
Scientific 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
Secondary ID [1] 0 0
ORIC-114-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Effect in Healthy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ORIC-114

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

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.

Experimental: Part 2 Treatment A - xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.

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.


Treatment: Drugs: ORIC-114
Food effect healthy subjects
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
14 days
Primary outcome [3] 0 0
Area under the curve (AUC)
Timepoint [3] 0 0
14 days
Primary outcome [4] 0 0
Apparent plasma terminal elimination half-life (t1/2)
Timepoint [4] 0 0
14 days
Secondary outcome [1] 0 0
Number of subjects with Treatment Emergent Adverse Effect
Timepoint [1] 0 0
30 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2023
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd., 235 Ryrie St - Geelong
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ORIC Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06012721
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pratik S Multani, MD, MS
Address 0 0
ORIC Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06012721