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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLG | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imlunestrant (Normal Hepatic Function) | Experimental | Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state. |
|
| Imlunestrant (Mild Hepatic Impairment) | Experimental | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
|
| Imlunestrant (Moderate Hepatic Impairment) | Experimental | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
|
| Imlunestrant (Severe Hepatic Impairment) | Experimental | Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlunestrant | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant | PK: Cmax of Imlunestrant is reported. | 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. | 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) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imlunestrant (Normal Hepatic Function) | Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state. |
| FG001 | Imlunestrant (Mild Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| FG002 | Imlunestrant (Moderate Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| FG003 | Imlunestrant (Severe Hepatic Impairment) | Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Imlunestrant (Normal Hepatic Function) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| BG001 | Imlunestrant (Mild Hepatic Impairment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant | PK: Cmax of Imlunestrant is reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 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) |
|
Baseline up to 18 days
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imlunestrant (Normal Hepatic Function) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2023 | Oct 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2024 | Oct 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
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|
| Orlando |
| Florida |
| 32809 |
| United States |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | United States |
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
| BG002 | Imlunestrant (Moderate Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| BG003 | Imlunestrant (Severe Hepatic Impairment) | Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | Imlunestrant (Moderate Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. |
| OG003 | Imlunestrant (Severe Hepatic Impairment) | Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. |
|
|
| Primary | 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. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | 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) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Imlunestrant (Mild Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Imlunestrant (Moderate Hepatic Impairment) | Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. | 0 | 6 | 1 | 6 | 2 | 6 |
| EG003 | Imlunestrant (Severe Hepatic Impairment) | Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. | 0 | 6 | 0 | 6 | 2 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
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