A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05444556
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 113
Inclusion Criteria
- Participants who are overtly healthy as determined by medical assessment
- Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
- Female participants of non childbearing potential.
Exclusion Criteria
- Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
- Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Imlunestrant + Omeprazole & Dextromethorphan Imlunestrant Omeprazole administered in combination with dextromethorphan orally on day 1 followed by imlunestrant administered orally in combination with omeprazole and dextromethorphan orally on day 3. Imlunestrant + Rosuvastatin & Digoxin Imlunestrant Rosuvastatin administered in combination with digoxin administered orally on day 1 followed by imlunestrant administered orally in combination with rosuvastatin and digoxin orally on day 10. Imlunestrant + Repaglinide Imlunestrant Repaglinide administered orally alone on day 1 followed by imlunestrant administered orally in combination with repaglinide orally on day 3. Imlunestrant + Quinidine Imlunestrant Imlunestrant administered orally on day 1 followed by quinidine alone orally on day 15 to 17. On day 18, imlunestrant administered orally in combination with quinidine followed by quinidine administered orally on day 19 to 24. Imlunestrant + Omeprazole & Dextromethorphan Omeprazole Omeprazole administered in combination with dextromethorphan orally on day 1 followed by imlunestrant administered orally in combination with omeprazole and dextromethorphan orally on day 3. Imlunestrant + Repaglinide Repaglinide Repaglinide administered orally alone on day 1 followed by imlunestrant administered orally in combination with repaglinide orally on day 3. Imlunestrant + Omeprazole & Dextromethorphan Dextromethorphan Omeprazole administered in combination with dextromethorphan orally on day 1 followed by imlunestrant administered orally in combination with omeprazole and dextromethorphan orally on day 3. Imlunestrant + Quinidine Quinidine Imlunestrant administered orally on day 1 followed by quinidine alone orally on day 15 to 17. On day 18, imlunestrant administered orally in combination with quinidine followed by quinidine administered orally on day 19 to 24. Imlunestrant + Rosuvastatin & Digoxin Rosuvastatin Rosuvastatin administered in combination with digoxin administered orally on day 1 followed by imlunestrant administered orally in combination with rosuvastatin and digoxin orally on day 10. Imlunestrant + Rosuvastatin & Digoxin Digoxin Rosuvastatin administered in combination with digoxin administered orally on day 1 followed by imlunestrant administered orally in combination with rosuvastatin and digoxin orally on day 10.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide Predose up to 24 hours postdose PK: AUC\[0-∞\] of Repaglinide
PK: AUC[0-∞] of Imlunestrant Predose up to 168 hours postdose PK: AUC\[0-∞\] of Imlunestrant
PK: AUC[0-∞] of 5-hydroxyomeprazole Predose up to 48 hours postdose PK: AUC\[0-∞\] of 5-hydroxyomeprazole
PK: Cmax of 5-hydroxyomeprazole Predose up to 48 hours postdose PK: Cmax of 5-hydroxyomeprazole
PK: Cmax of Dextromethorphan Predose up to 48 hours postdose PK: Cmax of Dextromethorphan
PK: AUC[0-∞] of Dextromethorphan Predose up to 48 hours postdose PK: AUC\[0-∞\] of Dextromethorphan
PK: AUC[0-∞] of Dextrorphan Predose up to 48 hours postdose PK: AUC\[0-∞\] of Dextrorphan
PK: Cmax of Rosuvastatin Predose up to 120 hours postdose PK: Cmax of Rosuvastatin
PK: Maximum Observed Concentration (Cmax) of Repaglinide Predose up to 24 hours postdose PK: Cmax of Repaglinide
PK: AUC[0-∞] of Omeprazole Predose up to 48 hours postdose PK: AUC\[0-∞\] of Omeprazole
PK: Cmax of Omeprazole Predose up to 48 hours postdose PK: Cmax of Omeprazole
PK: Cmax of Imlunestrant Predose up to 168 hours postdose PK: Cmax of Imlunestrant
PK: Cmax of Dextrorphan Predose up to 48 hours postdose PK: Cmax of Dextrorphan
PK: AUC[0-∞] of Rosuvastatin Predose up to 120 hours postdose PK: AUC\[0-∞\] of Rosuvastatin
PK: AUC[0-∞] of Digoxin Predose up to 120 hours postdose PK: AUC\[0-∞\] of Digoxin
PK: Cmax of Digoxin Predose up to 120 hours postdose PK: Cmax of Digoxin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Altasciences Clinical Los Angeles, Inc
🇺🇸Cypress, California, United States
Qps-Mra, Llc
🇺🇸South Miami, Florida, United States
ICON Early Phase Services
🇺🇸San Antonio, Texas, United States