At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Imlunestrantdrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Non-childbearing potential women (surgically sterile, congenital anomaly, or postmenopausal)
- ✓BMI 18.0–42.0 kg/m² at screening
- ✓Healthy participants: normal liver function on medical history, physical exam, and screening
- ✓Hepatic impairment participants: chronic mild, moderate, or severe liver impairment (Child-Pugh scored), ≥6 months duration with no clinically significant changes in prior 90 days
Key exclusion· 8
- ✕Women of childbearing potential
- ✕Known allergies to imlunestrant or related compounds
- ✕History of alcoholism or drug/chemical abuse within 2 years
- ✕Blood product transfusion within 2 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Imlunestrant for Hepatic Insufficiency and Healthy. Completed, enrolled 27 participants across 3 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Insufficiency, Healthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionFeb 2024
TodayJul 2026
First PostedJun 30, 2022
Enrollment StartJul 5, 2022
Primary CompletionFeb 28, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.0 years ago
Interventions
Imlunestrantdrug
Administered orally.