A Study of Imlunestrant (LY3484356) in Healthy Women
- Registration Number
- NCT05509816
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Midazolam + Imlunestrant Imlunestrant Midazolam administered orally alone on day 1 followed by imlunestrant administered orally alone on days 3 to 8. On day 9, midazolam is administered orally in combination with imlunestrant orally. Midazolam + Imlunestrant Midazolam Midazolam administered orally alone on day 1 followed by imlunestrant administered orally alone on days 3 to 8. On day 9, midazolam is administered orally in combination with imlunestrant orally.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam Predose up to 48 hours postdose PK: AUC\[0-∞\] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam Predose up to 48 hours postdose PK: Cmax of Midazolam
- Secondary Outcome Measures
Name Time Method PK: AUC[0-∞] of 1'-hydroxymidazolam Predose up to 48 hours postdose PK: AUC\[0-∞\] of 1'-hydroxymidazolam
PK: Cmax of 1'-hydroxymidazolam Predose up to 48 hours postdose PK: Cmax of 1'-hydroxymidazolam
PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant Predose up to 24 hours postdose PK: AUC\[0-24\], ss of Imlunestrant
PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant Predose up to 24 hours postdose PK: Cmax, ss of Imlunestrant
Trial Locations
- Locations (1)
LabCorp CRU, Inc.
🇺🇸Dallas, Texas, United States