HealthyPhase 1NCT05205447
Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants
A Phase 1 study testing LY3410738, Itraconazole and Carbamazepine 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 learn about how itraconazole and carbamazepine affect the levels of LY3410738 in the blood stream of healthy participants. Participation could last up to 75 days. 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?
- LY3410738, Itraconazole and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 12 Apr 2022
- 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
- Females of non-childbearing potential and males capable of fathering a child must use contraception
- Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
- Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
- Able to comply with all study procedures, including the 15-night stay for those participating in part 1 or 25-night stay for those participating in part 2 at the Clinical Research Unit and follow-up phone call.
Who cannot join
- History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- Allergic disease
- Dermatological disease
- Renal disease
- Liver disease
- Pancreatitis
Show all 33Show fewer
- Gastrointestinal disease
- Biliary disease
- Metabolic disease
- Hematological disease
- Pulmonary disease
- Neurological disease
- Cancer within the past 5 years
- Cardiovascular disease
- Participants with out-of-range, at-rest vital signs.
- Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
- Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
- Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
- Use or intention to use any prescription or over-the-counter medications within 14 days or 5 half-lives (if known) prior to the first dose administration (Day 1) and through end of trial.
- History or presence of any illness or psychiatric condition, that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
- Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
- Receipt of blood products within 2 months prior to Check-in (Day -1).
- Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- For Part 1 only, Having impaired hearing or a history of hearing problems
- For Part 2 only, History of serious dermatological adverse reaction, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or DRESS
- For Part 2 only, Glaucoma or history of elevated intraocular pressure.
- For Part 2 only, Have answered 'yes' to either Question 4 or Question 3 on the 'Suicidal Ideation' portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or have answered 'yes' to any of the suicide-related behaviors on the 'Suicidal Behavior' portion of the C-SSRS
- For Part 2 only, Have laboratory evidence of clinically significant anemia, leukopenia, thrombocytopenia, or hepatic dysfunction; or hyponatremia
- For Part 2 only, Genotyping test that is positive for either or both of the carbamazepine sensitivity conferring HLA alleles
- Creatinine clearance < 90 mL/minute calculated using the C-G equation at Screening or Check-in
- Known ongoing alcohol and/or drug abuse within 2 years prior to Screening, or evidence of such abuse as indicated by the laboratory assays for drugs of abuse (including cotinine and alcohol) conducted during Screening and/or at Check-in (Day- 1).
- Consumption of foods or beverages containing grapefruit/grapefruit juice or Seville oranges or their juice within 7 days prior to Check-in (Day -1) and through end of treatment (EOT) or early termination (ET)
- Have previously completed or withdrawn from this study or any other study investigating LY3410738, and have previously received LY3410738
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Carbamazepine on the Single-dose Pharmacokinetics of LY3410738 in Healthy Adult Subjects
The main purpose of this study is to learn about how itraconazole and carbamazepine affect the levels of LY3410738 in the blood stream of healthy participants. Participation could last up to 75 days.
- Conditions
- Healthy
- Being tested
- LY3410738, Itraconazole, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3410738Drug
Oral LY3410738
ItraconazoleDrug
Oral Itraconazole
CarbamazepineDrug
Oral Carbamazepine
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Period 1 (LY3410738 Alone) | Experimental | Single dose of LY3410738 administered orally. Receives: Drug: LY3410738 |
| Part 1 Period 2 (LY3410738 + Itraconazole) | Experimental | Single dose of LY3410738 administered orally with multiple doses of itraconazole orally. Receives: Drug: LY3410738; Drug: Itraconazole |
| Part 2 Period 1 (LY3410738 Alone) | Experimental | Single dose of LY3410738 administered orally. Receives: Drug: LY3410738 |
| Part 2 Period 2 (LY3410738 + Carbamazepine) | Experimental | Single dose of LY3410738 administered orally with multiple doses of carbamazepine orally. Receives: Drug: LY3410738; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of multiple oral doses of itraconazole on single oral dose pharmacokinetics (PK) of LY3410738 by collecting/evaluating serum at protocol-specified time points: Maximum observed plasma concentration (Cmax)
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve from Hour 0 to last measurable concentration (AUC0-t)
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve extrapolated to infinity (AUC0-inf)
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Cmax
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-t
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-inf
PK of LY3410738
Measured: Pre-dose up to 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start5 Jan 2022
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Why it stopped: Data from part 2 no longer deemed necessary for this program.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 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, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205447
- Sponsor's protocol ID
- LOXO-IDH-21005
- Other IDs
- I9Y-OX-JDHF
- Status last verified
- Dec 2022
- First submitted
- 5 Jan 2022
- Last updated
- 28 Dec 2022
- 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Carbamazepine on the Single-dose Pharmacokinetics of LY3410738 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05205447
- Acronym / sponsor ID
- LOXO-IDH-21005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data from part 2 no longer deemed necessary for this program.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 25 Jan 2022 (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 learn about how itraconazole and carbamazepine affect the levels of LY3410738 in the blood stream of healthy participants. Participation could last up to 75 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Period 1 (LY3410738 Alone) | Experimental | Drug: LY3410738Single dose of LY3410738 administered orally. |
| Part 1 Period 2 (LY3410738 + Itraconazole) | Experimental | Drug: LY3410738, Drug: ItraconazoleSingle dose of LY3410738 administered orally with multiple doses of itraconazole orally. |
| Part 2 Period 1 (LY3410738 Alone) | Experimental | Drug: LY3410738Single dose of LY3410738 administered orally. |
| Part 2 Period 2 (LY3410738 + Carbamazepine) | Experimental | Drug: LY3410738, Drug: CarbamazepineSingle dose of LY3410738 administered orally with multiple doses of carbamazepine orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females of non-childbearing potential and males capable of fathering a child must use contraception
- Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
- Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
- Able to comply with all study procedures, including the 15-night stay for those participating in part 1 or 25-night stay for those participating in part 2 at the Clinical Research Unit and follow-up phone call.
Key exclusion criteria (33 listed)
- History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- Participants with out-of-range, at-rest vital signs.
- Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
- Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
- Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
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 |
|---|---|---|
| LY3410738Oral LY3410738 | Drug | Part 1 Period 1 (LY3410738 Alone), Part 1 Period 2 (LY3410738 + Itraconazole), Part 2 Period 1 (LY3410738 Alone), Part 2 Period 2 (LY3410738 + Carbamazepine) |
| ItraconazoleOral Itraconazole | Drug | Part 1 Period 2 (LY3410738 + Itraconazole) |
| CarbamazepineOral Carbamazepine | Drug | Part 2 Period 2 (LY3410738 + Carbamazepine) |
Primary outcome
Assess the impact of multiple oral doses of itraconazole on single oral dose pharmacokinetics (PK) of LY3410738 by collecting/evaluating serum at protocol-specified time points: Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve from Hour 0 to last measurable concentration (AUC0-t)
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve extrapolated to infinity (AUC0-inf)
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Cmax
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-t
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-inf
Time frame: Pre-dose up to 96 hours post-dose
PK of LY3410738
Results and safety
The study was stopped early (reason given: Data from part 2 no longer deemed necessary for this program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- 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 study director
Medical Monitor
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 LY3410738, Itraconazole and Carbamazepine 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 4 inclusion and 33 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: stopped early, as of the sponsor's last update on 28 Dec 2022. 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 was stopped early (reason given: Data from part 2 no longer deemed necessary for this program.). Results are not available in the source record.
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?
Assess the impact of multiple oral doses of itraconazole on single oral dose pharmacokinetics (PK) of LY3410738 by collecting/evaluating serum at protocol-specified time points: Maximum observed plasma concentration (Cmax) (time frame: Pre-dose up to 96 hours post-dose). 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 28 Dec 2022.