NCT05444556

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Imlunestrant	Administered orally.
DRUG	Repaglinide	Administered orally.
DRUG	Omeprazole	Administered orally.
DRUG	Dextromethorphan	Administered orally.
DRUG	Quinidine	Administered orally.
DRUG	Rosuvastatin	Administered orally.
DRUG	Digoxin	Administered orally.

Timeline

• Start date: 2022-07-07
• Primary completion: 2022-11-02
• Completion: 2022-11-02
• First posted: 2022-07-06
• Last updated: 2025-12-12
• Results posted: 2025-12-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study