A Phase 1 interventional study of Imlunestrant in Hepatic Insufficiency and Healthy, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female participants with normal liver function. The side effects and tolerability of Imlunestrant will also be evaluated. The study may last up to 46 days for each participant.
325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.
This study's enrollment of 27 is below the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
All Participants:
Healthy Participants:
- Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function
Participants with Impaired Liver Function:
Exclusion Criteria:
Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.
Drug: Imlunestrant
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Drug: Imlunestrant
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Drug: Imlunestrant
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
Drug: Imlunestrant
Administered orally.
Also known as: LY3484356
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
PK: Cmax of Imlunestrant is reported.
Time frame: Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)
PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant
AUC(0-t) of Imlunestrant is reported.
Time frame: Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)
| Milestone | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Started | 9 | 6 | 6 | 6 |
| Received at least one dose of study drug | 9 | 6 | 6 | 6 |
| Completed | 9 | 6 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
PK: Cmax of Imlunestrant is reported.
| nanograms per milliliter (ng/mL) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant | 58.0 ± 56 | 74.9 ± 47 | 87.6 ± 51 | 46.2 ± 49 |
AUC(0-t) of Imlunestrant is reported.
| nanograms*hour per milliliter (ng*h/mL) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) |
|---|---|---|---|---|
| PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant | 1970 ± 51 | 2410 ± 27 | 4320 ± 50 | 2820 ± 47 |
Collected over Baseline up to 18 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imlunestrant (Normal Hepatic Function) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Imlunestrant (Mild Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Imlunestrant (Moderate Hepatic Impairment) | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) |
| Imlunestrant (Severe Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Portal vein thrombosisHepatobiliary disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| Event | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/9 | 0/6 | 2/6 | 1/6 |
| Abdominal pain upperGastrointestinal disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| VomitingGastrointestinal disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| FallInjury, poisoning and procedural complications | 0/9 | 0/6 | 0/6 | 1/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| Back painMusculoskeletal and connective tissue disorders | 0/9 | 0/6 | 0/6 | 1/6 |
| HeadacheNervous system disorders | 0/9 | 0/6 | 1/6 | 1/6 |
| InsomniaPsychiatric disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| PruritusSkin and subcutaneous tissue disorders | 0/9 | 0/6 | 1/6 | 0/6 |
| RashSkin and subcutaneous tissue disorders | 0/9 | 0/6 | 0/6 | 1/6 |
All enrolled participants.
| Age, Continuous(years) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Mean | 60.3 ± 5.0 | 66.7 ± 3.1 | 59.2 ± 8.3 | 57.3 ± 3.1 | 60.8 ± 6.0 |
| Sex: Female, Male(Participants) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Female | 9 | 6 | 6 | 6 | 27 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 3 | 3 | 15 |
| Not Hispanic or Latino | 5 | 1 | 3 | 3 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 1 |
| White | 8 | 6 | 5 | 6 | 25 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Imlunestrant (Normal Hepatic Function) | Imlunestrant (Mild Hepatic Impairment) | Imlunestrant (Moderate Hepatic Impairment) | Imlunestrant (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| United States | 9 | 6 | 6 | 6 | 27 |
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Eli Lilly and Company