HealthyPhase 1NCT05860933
A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants
A Phase 1 study testing LY3537982, Itraconazole and Carbamazepine in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. 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?
- LY3537982, Itraconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2023to 28 Aug 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
2 sites in 1 country.
United States2 sites
ICON Early Development Services
Salt Lake City, Utah, 84124
ICON Early Development Services
San Antonio, Texas, 78209
About this study
Official title: A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects
The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.
- Conditions
- Healthy
- Being tested
- LY3537982, Itraconazole, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537982Drug
Also called Olomorasib
Administered orally.
ItraconazoleDrug
Administered orally.
CarbamazepineDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3537982 + Itraconazole (Part 1) | Experimental | LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally. Receives: Drug: LY3537982; Drug: Itraconazole |
| LY3537982 + Carbamazepine (Part 2) | Experimental | LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally. Receives: Drug: LY3537982; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole
PK: Cmax of LY3537982 administered with or without itraconazole
Measured: Predose on day 1 up to 72 hours postdose on day 9
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole
PK: AUC[0-inf] of LY3537982 administered with or without itraconazole
Measured: Predose on day 1 up to 72 hours postdose on day 9
PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole
PK: AUClast of LY3537982 administered with or without itraconazole
Measured: Predose on day 1 up to 72 hours postdose on day 9
PK: Cmax of LY3537982 administered with or without carbamazepine
PK: Cmax of LY3537982 administered with or without carbamazepine
Measured: Predose on day 1 up to 72 hours postdose on day 13
PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
Measured: Predose on day 1 up to 72 hours postdose on day 13
PK: AUClast of LY3537982 administered with or without carbamazepine
PK: AUClast of LY3537982 administered with or without carbamazepine
Measured: Predose on day 1 up to 72 hours postdose on day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start8 May 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT05860933
- Sponsor's protocol ID
- LOXO-RAS-22002
- Other IDs
- J3M-OX-JZQD
- Status last verified
- Nov 2024
- First submitted
- 8 May 2023
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05860933
- Acronym / sponsor ID
- LOXO-RAS-22002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Study start
- 8 May 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 16 May 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 the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3537982 + Itraconazole (Part 1) | Experimental | Drug: LY3537982, Drug: ItraconazoleLY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally. |
| LY3537982 + Carbamazepine (Part 2) | Experimental | Drug: LY3537982, Drug: CarbamazepineLY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally. |
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 |
|---|---|---|
| LY3537982Also: OlomorasibAdministered orally. | Drug | LY3537982 + Carbamazepine (Part 2), LY3537982 + Itraconazole (Part 1) |
| ItraconazoleAdministered orally. | Drug | LY3537982 + Itraconazole (Part 1) |
| CarbamazepineAdministered orally. | Drug | LY3537982 + Carbamazepine (Part 2) |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: Cmax of LY3537982 administered with or without itraconazole
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: AUC[0-inf] of LY3537982 administered with or without itraconazole
PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole
Time frame: Predose on day 1 up to 72 hours postdose on day 9
PK: AUClast of LY3537982 administered with or without itraconazole
PK: Cmax of LY3537982 administered with or without carbamazepine
Time frame: Predose on day 1 up to 72 hours postdose on day 13
PK: Cmax of LY3537982 administered with or without carbamazepine
PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
Time frame: Predose on day 1 up to 72 hours postdose on day 13
PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
PK: AUClast of LY3537982 administered with or without carbamazepine
Time frame: Predose on day 1 up to 72 hours postdose on day 13
PK: AUClast of LY3537982 administered with or without carbamazepine
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 8 Nov 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.
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 LY3537982, Itraconazole and Carbamazepine in people with Healthy, run by Eli Lilly and Company at 2 sites 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 8 Nov 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 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 LY3537982 administered with or without itraconazole (time frame: Predose on day 1 up to 72 hours postdose on day 9). 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 8 Nov 2024.