Phase 1
N=20
A Study of Imlunestrant (LY3484356) in Healthy Women
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05509816 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam — 12.3; 11.4 nanogram*hour per milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Midazolam (Drug); Imlunestrant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam |
12.3; 11.4 | — |
| PRIMARY PK: Maximum Observed Concentration (Cmax) of Midazolam |
3.84; 4.12 | — |
| SECONDARY PK: AUC[0-∞] of 1'-Hydroxymidazolam |
2.75; 2.26 | — |
| SECONDARY PK: Cmax of 1'-Hydroxymidazolam |
0.748; 0.722 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam |
2020 | — |
| SECONDARY PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam |
120 | — |
Summary
The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.
Eligibility Criteria
Inclusion Criteria
- Women not of childbearing potential
- Participants who are overtly healthy as determined by medical assessment
- Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive
Exclusion Criteria
- Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- Use or intend to use medications that are substrate drugs of P-glycoprotein
Data sourced from ClinicalTrials.gov (NCT05509816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.