HealthyPhase 1NCT06181084

A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

A Phase 1 study testing LY3410738 and Esomeprazole in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3410738 and Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2021to 28 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

Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator.
Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.
Must have comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call.

Who cannot join

History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor.
Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
Positive polymerase chain reaction (PCR) test for COVID-19 at Screening.
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 (or designee).
Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1.
Have history of a major surgical procedure within 30 days prior to Screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Labcorp Clinical Research
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Pilot Study Comparing LY3410738 Capsule and Tablet Formulations and Effect of a Low-fat Meal and a Proton Pump Inhibitor on the Single-dose Pharmacokinetics of LY3410738 Tablets in Healthy Adult Subjects

The main purpose of study is to compare different formulations of LY3410738 under fasting condition by looking at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. The study will also access the effect of standard low-fat meal and esomeprazole (Proton Pump Inhibitor) on LY3410738. Safety and tolerability of LY3410738 will also be evaluated. For each participant, the total duration of the study will be 56 days for Groups 1 and 2 and up to 61 days for Groups 3 and 4, including screening.

Conditions: Healthy
Being tested: LY3410738, Esomeprazole
Keywords: Formulation, food effect, proton pump inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3410738Drug
Administered orally.
EsomeprazoleDrug
Administered orally.

Study groups in NCT06181084
Study group	Role	What they receive
Group 1: Tablet versus Capsule	Experimental	Treatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing. Receives: Drug: LY3410738
Group 2: Food Effect Comparison Group	Experimental	Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Receives: Drug: LY3410738
Group 3: Potential of Hydrogen (pH) Effect Fasted Group	Experimental	Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration. Receives: Drug: LY3410738; Drug: Esomeprazole
Group 4: pH Effect Fed Group	Experimental	Treatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal. Receives: Drug: LY3410738; Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules
PK: AUC0-tlast of LY3410738 Tablets Versus Capsules
Measured: Predose up to 48 hours postdose
PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules
PK: AUC0-∞ of LY3410738 Tablets Versus Capsules
Measured: Predose up to 48 hours postdose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules
PK: Cmax of LY3410738 Tablets Versus Capsules
Measured: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
Measured: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
Measured: Predose up to 48 hours postdose
PK: Cmax of LY3410738 After Standard Low-Fat Meal
PK: Cmax of LY3410738 After Standard Low-Fat Meal
Measured: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
Measured: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
Measured: Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
Measured: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
Measured: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
Measured: Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State
Measured: Predose up to 48 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202128 Apr 2022

First posted26 Dec 2023
Study start11 Oct 2021
Primary completion28 Apr 2022
Study completion28 Apr 2022

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
Model description: Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06181084
Sponsor's protocol ID: LOXO-IDH-21004
Other IDs: I9Y-OX-JDHE
Status last verified: Dec 2023
First submitted: 13 Dec 2023
Last updated: 26 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Comparing LY3410738 Capsule and Tablet Formulations and Effect of a Low-fat Meal and a Proton Pump Inhibitor on the Single-dose Pharmacokinetics of LY3410738 Tablets in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06181084
Acronym / sponsor ID: LOXO-IDH-21004
Conditions: Healthy
Keywords: Formulation, food effect, proton pump inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Loxo Oncology, Inc.
Study start: 11 Oct 2021 (actual)
Primary completion: 28 Apr 2022 (actual)
Study completion: 28 Apr 2022 (actual)
First posted: 26 Dec 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.

Arm	Type	Receives
Group 1: Tablet versus Capsule	Experimental	Drug: LY3410738Treatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing.
Group 2: Food Effect Comparison Group	Experimental	Drug: LY3410738Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal.
Group 3: Potential of Hydrogen (pH) Effect Fasted Group	Experimental	Drug: LY3410738, Drug: EsomeprazoleTreatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration.
Group 4: pH Effect Fed Group	Experimental	Drug: LY3410738, Drug: EsomeprazoleTreatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator.
Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.
Must have comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call.

Key exclusion criteria (7 listed)

History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor.
Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
Positive polymerase chain reaction (PCR) test for COVID-19 at Screening.
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 (or designee).

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
LY3410738Administered orally.	Drug	Group 1: Tablet versus Capsule, Group 2: Food Effect Comparison Group, Group 3: Potential of Hydrogen (pH) Effect Fasted Group, Group 4: pH Effect Fed Group
EsomeprazoleAdministered orally.	Drug	Group 3: Potential of Hydrogen (pH) Effect Fasted Group, Group 4: pH Effect Fed Group

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules
Time frame: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 Tablets Versus Capsules
PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules
Time frame: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 Tablets Versus Capsules
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules
Time frame: Predose up to 48 hours postdose
PK: Cmax of LY3410738 Tablets Versus Capsules
PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
Time frame: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
Time frame: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
PK: Cmax of LY3410738 After Standard Low-Fat Meal
Time frame: Predose up to 48 hours postdose
PK: Cmax of LY3410738 After Standard Low-Fat Meal
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
Time frame: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
Time frame: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
Time frame: Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
Time frame: Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
Time frame: Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State
Time frame: Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State

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 26 Dec 2023.
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 LY3410738 and Esomeprazole 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 7 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 26 Dec 2023. 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): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules (time frame: Predose up to 48 hours postdose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06181084.

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 26 Dec 2023.