Trial Outcomes & Findings for A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function (NCT NCT05440344)
NCT ID: NCT05440344
Last Updated: 2025-11-12
Results Overview
PK: Cmax of Imlunestrant is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
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)
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Imlunestrant (Moderate Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Normal Hepatic Function)
Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
9
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
6
|
9
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
Baseline characteristics by cohort
| Measure |
Imlunestrant (Normal Hepatic Function)
n=9 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Moderate Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 5.0 • n=10 Participants
|
66.7 years
STANDARD_DEVIATION 3.1 • n=10 Participants
|
59.2 years
STANDARD_DEVIATION 8.3 • n=20 Participants
|
57.3 years
STANDARD_DEVIATION 3.1 • n=45 Participants
|
60.8 years
STANDARD_DEVIATION 6.0 • n=44 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
27 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
15 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
12 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
25 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
27 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 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)Population: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of Imlunestrant is reported.
Outcome measures
| Measure |
Imlunestrant (Normal Hepatic Function)
n=9 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Moderate Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
n=6 Participants
Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1 in fasted state.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
|
58.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
74.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
87.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
46.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: 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)Population: All participants who received at least one dose of study drug and had evaluable PK data.
AUC(0-t) of Imlunestrant is reported.
Outcome measures
| Measure |
Imlunestrant (Normal Hepatic Function)
n=9 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Moderate Hepatic Impairment)
n=6 Participants
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
n=6 Participants
Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1 in fasted state.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant
|
1970 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 51
|
2410 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
4320 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
|
2820 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
Adverse Events
Imlunestrant (Normal Hepatic Function)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Imlunestrant (Mild Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Imlunestrant (Moderate Hepatic Impairment)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Imlunestrant (Severe Hepatic Impairment)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imlunestrant (Normal Hepatic Function)
n=9 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Moderate Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Imlunestrant (Normal Hepatic Function)
n=9 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Mild Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Moderate Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
|
Imlunestrant (Severe Hepatic Impairment)
n=6 participants at risk
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to 18 days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60