HealthyPhase 1NCT06102512
A Study of [14C]-LOXO-783 in Healthy Adult Participants
A Phase 1 study testing [¹⁴C]-LOXO-783 and 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 evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. 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?
- [¹⁴C]-LOXO-783 and LOXO-783
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 17 Jan 2024
- 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
- Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
- Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
Who cannot join
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects
The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.
- Conditions
- Healthy
- Being tested
- [¹⁴C]-LOXO-783, LOXO-783
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]-LOXO-783Drug
Also called LY3849524
Administered orally
LOXO-783Drug
Also called LY3849524
Administered orally
[¹⁴C]-LOXO-783Drug
Also called LY3849524
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C]-LOXO-783 (Part 1) | Experimental | Single dose of [¹⁴C]-LOXO-783 administered orally Receives: Drug: [¹⁴C]-LOXO-783 |
| LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) | Experimental | Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV) Receives: Drug: LOXO-783; Drug: [¹⁴C]-LOXO-783 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)
PK: Feur
Measured: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Cumulative Feur
PK: Cumulative Feur
Measured: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Fraction of Dose Excreted in Feces (Fefeces)
PK: Fefeces
Measured: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Cumulative Fefeces
PK: Cumulative Fefeces
Measured: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Fraction of Dose Excreted in Expired Air (Feair)
PK: Feair
Measured: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Absolute Bioavailability (F) of LOXO-783
PK: F of LOXO-783
Measured: Predose on day 1 up to postdose on day 9 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start23 Oct 2023
- Primary completion23 Dec 2023
- Study completion17 Jan 2024
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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, Study director, Loxo Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102512
- Sponsor's protocol ID
- LOXO-PIK-23005
- Other IDs
- J4C-OX-JZUE
- Status last verified
- Jul 2024
- First submitted
- 23 Oct 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, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06102512
- Acronym / sponsor ID
- LOXO-PIK-23005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 26 Oct 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 evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C]-LOXO-783 (Part 1) | Experimental | Drug: [¹⁴C]-LOXO-783Single dose of [¹⁴C]-LOXO-783 administered orally |
| LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) | Experimental | Drug: LOXO-783, Drug: [¹⁴C]-LOXO-783Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
- Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
- Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
Key exclusion criteria (3 listed)
- History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
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 |
|---|---|---|
| [¹⁴C]-LOXO-783Also: LY3849524Administered orally | Drug | [¹⁴C]-LOXO-783 (Part 1) |
| LOXO-783Also: LY3849524Administered orally | Drug | LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) |
| [¹⁴C]-LOXO-783Also: LY3849524Administered IV | Drug | LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) |
Primary outcome
Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)
Time frame: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Feur
PK: Cumulative Feur
Time frame: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Cumulative Feur
PK: Fraction of Dose Excreted in Feces (Fefeces)
Time frame: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Fefeces
PK: Cumulative Fefeces
Time frame: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Cumulative Fefeces
PK: Fraction of Dose Excreted in Expired Air (Feair)
Time frame: Predose on day 1 up to postdose on day 21 (Part 1)
PK: Feair
PK: Absolute Bioavailability (F) of LOXO-783
Time frame: Predose on day 1 up to postdose on day 9 (Part 2)
PK: F 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 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 [¹⁴C]-LOXO-783 and 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 3 inclusion and 3 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): Fraction of Dose Excreted in Urine (Feur) (time frame: Predose on day 1 up to postdose on day 21 (Part 1)). The study lists 6 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.