HealthyPhase 1NCT06028425
A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants
A Phase 1 study testing LOXO-783 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LOXO-783
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 23 Dec 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 status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Who cannot join
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.
- Conditions
- Healthy
- Being tested
- LOXO-783
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOXO-783Drug
Also called LY3849524
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LOXO-783 (Fasted State) | Experimental | LOXO-783 administered orally to participants who are in fasted state Receives: Drug: LOXO-783 |
| LOXO-783 (Fed State - Low Fat Meal) | Experimental | LOXO-783 administered orally to participants who are on low fat meal Receives: Drug: LOXO-783 |
| LOXO-783 (Fed State - High Fat Meal) | Experimental | LOXO-783 administered orally to participants who are on high fat meal Receives: Drug: LOXO-783 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
PK: Cmax of LOXO-783
Measured: Predose on Day 1 up to 96 hours postdose
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783
PK: AUC [0-∞] of LOXO-783
Measured: Predose on Day 1 up to 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Sep 2023
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Yingying Guo-Avrutin, MD, PhD, Study director, Loxo Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028425
- Sponsor's protocol ID
- LOXO-PIK-22004
- Other IDs
- J4C-OX-JZUC
- Status last verified
- Jul 2024
- First submitted
- 1 Sep 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06028425
- Acronym / sponsor ID
- LOXO-PIK-22004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 8 Sep 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.
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LOXO-783 (Fasted State) | Experimental | Drug: LOXO-783LOXO-783 administered orally to participants who are in fasted state |
| LOXO-783 (Fed State - Low Fat Meal) | Experimental | Drug: LOXO-783LOXO-783 administered orally to participants who are on low fat meal |
| LOXO-783 (Fed State - High Fat Meal) | Experimental | Drug: LOXO-783LOXO-783 administered orally to participants who are on high fat meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Key exclusion criteria (2 listed)
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
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 |
|---|---|---|
| LOXO-783Also: LY3849524Administered orally. | Drug | LOXO-783 (Fasted State), LOXO-783 (Fed State - High Fat Meal), LOXO-783 (Fed State - Low Fat Meal) |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
Time frame: Predose on Day 1 up to 96 hours postdose
PK: Cmax of LOXO-783
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783
Time frame: Predose on Day 1 up to 96 hours postdose
PK: AUC [0-∞] of LOXO-783
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 22 Jul 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.
Yingying Guo-Avrutin, MD, PhD study director
Loxo Oncology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LOXO-783 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
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 2 inclusion and 2 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 (time frame: Predose on Day 1 up to 96 hours postdose). The study lists 2 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 22 Jul 2024.