NCT04840888

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

April 9, 2021

Results QC Date

October 22, 2025

Last Update Submit

November 25, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

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

    PK: AUC\[0-∞\] of LY3484356

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (6)

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

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.

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.

Drug: LY3484356Drug: 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.

Drug: LY3484356Drug: 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.

Drug: LY3484356Drug: 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).

Drug: CarbamazepineDrug: Midazolam

Interventions

LY3484356DRUG

Administered orally.

Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 FedCohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 FastedCohort 2: LY3484356 + OmeprazoleCohort 3: LY3484356 + ItraconazoleCohort 4: LY3484356 + Carbamazepine
OmeprazoleDRUG

Administered orally.

Cohort 2: LY3484356 + Omeprazole
ItraconazoleDRUG

Administered orally.

Cohort 3: LY3484356 + Itraconazole
CarbamazepineDRUG

Administered orally.

Cohort 4: LY3484356 + CarbamazepineCohort 5: Carbamazepine + Midazolam
MidazolamDRUG

Administered orally.

Cohort 5: Carbamazepine + Midazolam

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

ImlunestrantOmeprazoleItraconazoleCarbamazepineMidazolam

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTriazolesAzolesPiperazinesDibenzazepinesHeterocyclic Compounds, 3-RingBenzodiazepinesBenzazepines

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 12, 2021

Study Start

April 26, 2021

Primary Completion

April 12, 2022

Study Completion

April 12, 2022

Last Updated

December 11, 2025

Results First Posted

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)