Food Effect in Healthy ParticipantsPhase 1NCT06012721
Effect of Food on the Pharmacokinetics of ORIC-114
A Phase 1 study testing ORIC-114 in people with Food Effect in Healthy Participants, run by ORIC Pharmaceuticals at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect in Healthy Participants
- What is being tested?
- ORIC-114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesAustralia
- Study dates
- 11 Sep 2023to 23 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network Pty Ltd., 235 Ryrie St
Geelong, Victoria, 3220
Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd
Melbourne, Victoria, 3004
About this study
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
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.
Read the 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.
- Conditions
- Food Effect in Healthy Participants
- Being tested
- ORIC-114
- Keywords
- Food effect, ORIC-114
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIC-114Drug
Food effect healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Treatment A | Experimental | 30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: ORIC-114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Measured: 14 days
Time of maximum observed concentration (Tmax)
Food Effect: PK of ORIC-114 tablet
Measured: 14 days
Area under the curve (AUC)
Food Effect: PK of ORIC-114 tablet
Measured: 14 days
Apparent plasma terminal elimination half-life (t1/2)
Food Effect: PK of ORIC-114 tablet
Measured: 14 days
Secondary outcomes (1)
Number of subjects with Treatment Emergent Adverse Effect
Assessed by NCI CTCAE v5.0
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Sep 2023
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Effect in Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORIC Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pratik S Multani, MD, MS, Study director, ORIC Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012721
- Sponsor's protocol ID
- ORIC-114-03
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06012721
- Acronym / sponsor ID
- ORIC-114-03
- Conditions
- Food Effect in Healthy Participants
- Keywords
- Food effect, ORIC-114
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ORIC PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
| Arm | Type | Receives |
|---|---|---|
| Part 1 Treatment A | Experimental | Drug: ORIC-11430 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
| Part 1 Treatment B | Experimental | Drug: ORIC-11430 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 | Experimental | Drug: ORIC-114xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
| Part 2 Treatment B | Experimental | Drug: ORIC-114xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIC-114Food effect healthy subjects | Drug | Part 1 Treatment A, Part 1 Treatment B, Part 2 Treatment A, Part 2 Treatment B |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 14 days
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Time of maximum observed concentration (Tmax)
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
Area under the curve (AUC)
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
Apparent plasma terminal elimination half-life (t1/2)
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
1 secondary outcome
Number of subjects with Treatment Emergent Adverse Effect
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratik S Multani, MD, MS study director
ORIC Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORIC-114 in people with Food Effect in Healthy Participants, run by ORIC Pharmaceuticals at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.