HealthyPhase 1NCT04840888

A Study of LY3484356 in Healthy Female Participants

A Phase 1 study testing LY3484356, Omeprazole and Itraconazole in people with Healthy, run by Eli Lilly and Company at 2 sites 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 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3484356, Omeprazole and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 2 sitesUnited States
Study dates: 26 Apr 2021to 12 Apr 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants who are overtly healthy as determined by medical assessment
Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
Female participants of non childbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, bilateral tubal ligation, or bilateral tubal occlusion), or alternate medical cause/congenital anomaly (for example, Müllerian agenesis) or postmenopausal

Who cannot join

Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Show evidence of hepatitis B, evidence of hepatitis C and/or have evidence of human immunodeficiency virus (HIV) infection
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
Use or intend to use medications that inhibit or induce CYP3A4 within 14 days prior to dosing until completion of the follow-up visit
Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance Dallas
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: Evaluation of the Effect of Food, Omeprazole, Itraconazole, and Carbamazepine on the Pharmacokinetics of LY3484356 in Healthy Females of Non-Child-Bearing Potential

The main purpose of this study is to evaluate the amount of LY3484356 that is found in the blood stream and how long the body takes to get rid of it when given with and without food. Participants are healthy females of non-childbearing potential. The study will also evaluate the tolerability and safety of LY3484356 by collecting the information about any side effects that may occur. The participant's involvement with the study will last approximately 27 days, not including screening.

Conditions: Healthy
Being tested: LY3484356, Omeprazole, Itraconazole, Carbamazepine, Midazolam

What participants receive

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

LY3484356Drug
Administered orally.
OmeprazoleDrug
Administered orally.
ItraconazoleDrug
Administered orally.
CarbamazepineDrug
Administered orally.
MidazolamDrug
Administered orally.

Study groups in NCT04840888
Study group	Role	What they receive
Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed	Experimental	Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356 Receives: Drug: LY3484356
Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted	Experimental	Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. There was a washout period of 4 days between doses of LY3484356. Receives: Drug: LY3484356
Cohort 2: LY3484356 + Omeprazole	Experimental	Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356. Receives: Drug: LY3484356; Drug: Omeprazole
Cohort 3: LY3484356 + Itraconazole	Experimental	Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356. Receives: Drug: LY3484356; Drug: Itraconazole
Cohort 4: LY3484356 + Carbamazepine	Experimental	Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356. Receives: Drug: LY3484356; Drug: Carbamazepine
Cohort 5: Carbamazepine + Midazolam	Experimental	Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose). Receives: Drug: Carbamazepine; Drug: Midazolam

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)
PK: AUC[0-∞] of LY3484356
Measured: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
PK: AUC[0-∞] of LY3484356 (Cohort 2)
PK: AUC[0-∞] of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: AUC[0-∞] of LY3484356 (Cohort 3)
PK: AUC[0-∞] of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: AUC[0-∞] of LY3484356 (Cohort 4)
AUC[0-∞] of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)
PK: Tmax of LY3484356
Measured: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
PK: Tmax of LY3484356 (Cohort 2)
PK: Tmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Tmax of LY3484356 (Cohort 3)
PK: Tmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Tmax of LY3484356 (Cohort 4)
Tmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)
Cmax of LY3484356
Measured: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
PK: Cmax of LY3484356 (Cohort 2)
Cmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Cmax of LY3484356 (Cohort 3)
Cmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Cmax of LY3484356 (Cohort 4)
Cmax of LY3484356
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Timeline

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

26 Apr 202112 Apr 2022

First posted12 Apr 2021
Study start26 Apr 2021
Primary completion12 Apr 2022
Study completion12 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04840888
Sponsor's protocol ID: 18204
Other IDs: J2J-MC-JZLD
Status last verified: Nov 2025
First submitted: 9 Apr 2021
Last updated: 11 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Food, Omeprazole, Itraconazole, and Carbamazepine on the Pharmacokinetics of LY3484356 in Healthy Females of Non-Child-Bearing Potential
ClinicalTrials.gov ID: NCT04840888
Acronym / sponsor ID: 18204
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 26 Apr 2021 (actual)
Primary completion: 12 Apr 2022 (actual)
Study completion: 12 Apr 2022 (actual)
First posted: 12 Apr 2021 (actual)
Results: Posted 11 Dec 2025

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: 6

Arm	Type	Receives
Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed	Experimental	Drug: LY3484356Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356
Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted	Experimental	Drug: LY3484356Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. There was a washout period of 4 days between doses of LY3484356.
Cohort 2: LY3484356 + Omeprazole	Experimental	Drug: LY3484356, Drug: OmeprazoleParticipants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356.
Cohort 3: LY3484356 + Itraconazole	Experimental	Drug: LY3484356, Drug: ItraconazoleParticipants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356.
Cohort 4: LY3484356 + Carbamazepine	Experimental	Drug: LY3484356, Drug: CarbamazepineParticipants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356.
Cohort 5: Carbamazepine + Midazolam	Experimental	Drug: Carbamazepine, Drug: MidazolamParticipants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose).

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants who are overtly healthy as determined by medical assessment
Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
Female participants of non childbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, bilateral tubal ligation, or bilateral tubal occlusion), or alternate medical cause/congenital anomaly (for example, Müllerian agenesis) or postmenopausal

Key exclusion criteria (5 listed)

Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Show evidence of hepatitis B, evidence of hepatitis C and/or have evidence of human immunodeficiency virus (HIV) infection
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
Use or intend to use medications that inhibit or induce CYP3A4 within 14 days prior to dosing until completion of the follow-up visit
Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day

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
LY3484356Administered orally.	Drug	Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed, Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted, Cohort 2: LY3484356 + Omeprazole, Cohort 3: LY3484356 + Itraconazole, Cohort 4: LY3484356 + Carbamazepine
OmeprazoleAdministered orally.	Drug	Cohort 2: LY3484356 + Omeprazole
ItraconazoleAdministered orally.	Drug	Cohort 3: LY3484356 + Itraconazole
CarbamazepineAdministered orally.	Drug	Cohort 4: LY3484356 + Carbamazepine, Cohort 5: Carbamazepine + Midazolam
MidazolamAdministered orally.	Drug	Cohort 5: Carbamazepine + Midazolam

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)
Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
PK: AUC[0-∞] of LY3484356
PK: AUC[0-∞] of LY3484356 (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: AUC[0-∞] of LY3484356
PK: AUC[0-∞] of LY3484356 (Cohort 3)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: AUC[0-∞] of LY3484356
PK: AUC[0-∞] of LY3484356 (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
AUC[0-∞] of LY3484356
PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)
Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 3)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
Tmax of LY3484356
PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)
Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose
Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 3)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose
Cmax of LY3484356

Results and safety

Results posted to the registry on 11 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed	5	5
Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted	3	3
Cohort 2: LY3484356 + Omeprazole	10	9
Cohort 3: LY3484356 + Itraconazole	20	19
Cohort 4: LY3484356 + Carbamazepine	29	18
Cohort 5: Carbamazepine + Midazolam	15	14

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)

Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Cohort 1: 400 mg LY3484356 Fasted n = 4	Cohort 1: 400 mg LY3484356 Fed n = 6
Value	1810 (59)	4350 (39)

Population analysed: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: AUC[0-∞] of LY3484356 (Cohort 2)

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Cohort 2: LY3484356 + Omeprazole n = 4
Day 1	2270 (93)
Day 9	1960 (46)

Population analysed: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: AUC[0-∞] of LY3484356 (Cohort 3)

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Cohort 3: LY3484356 + Itraconazole n = 19
Day 1	1430 (58)
Day 10	3120 (41)

Population analysed: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: AUC[0-∞] of LY3484356 (Cohort 4)

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Cohort 4: LY3484356 + Carbamazepine n = 26
Day 1	1950 (67)
Day 18	1090 (32)

Population analysed: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.

Adverse events

Time frame: Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 400 mg LY3484356 Fasted	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Cohort 1: 400 mg LY3484356 Fed	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Cohort 2: 400 mg LY3484356 (Day 1)	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Cohort 2: 40 mg Omeprazole (Days 5 to 8)	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Cohort 2: 400 mg LY3484356 + 40 mg Omeprazole (Day 9)	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Cohort 3: 200 mg LY3484356 (Day 1)	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Cohort 3: 200 mg Itraconazole (Days 5 to 9)	0 of 20 (0%)	8 of 20 (40%)	0 of 20
Cohort 3: 200 mg LY3484356 + 200 mg Itraconazole (Days 10 to 16)	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Cohort 4: 400 mg LY3484356 (Day 1)	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
Cohort 4: 100 mg Carbamazepine (Days 6 to 8)	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Cohort 4: 200 mg Carbamazepine (Days 9 to 11)	0 of 28 (0%)	6 of 28 (21.4%)	0 of 28
Cohort 4: 300 mg Carbamazepine + 400 mg LY3484356 (Days 12 to 22)	1 of 28 (3.6%)	16 of 28 (57.1%)	0 of 28
Cohort 4: 300 mg Carbamazepine (Day 23)	0 of 20 (0%)	3 of 20 (15%)	0 of 20
Cohort 5: 1.2 mg Midazolam (Day 1)	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Cohort 5: 100 mg Carbamazepine (Days 2 to 4)	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Cohort 5: 200 mg Carbamazepine (Days 5 to 7)	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Cohort 5: 300 mg Carbamazepine (Days 8 to 10)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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 LY3484356, Omeprazole and Itraconazole 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 3 inclusion and 5 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 11 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1) (time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h 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 NCT04840888.

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 11 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.