A Phase 1, Open-Label, 4-Part Study to Investigate the Relative Bioavailability and Bioequivalence of Imlunestrant (LY3484356) Test and Reference Formulations and the Effects of Food and Omeprazole on the Pharmacokinetics of Imlunestrant, in Healthy Female Participants of Non-Childbearing Potential

Eli Lilly and Company

Summary

The main purpose of this study is to measure the amount of imlunestrant that gets into the bloodstream and how long it takes the body to get rid of it when given in two different formulations. This study also compares the two different formulations of imlunestrant against the effects of food and omeprazole in the body. For each participant, the study may last up to 2.5 months and participants can expect to stay in the clinical research unit (CRU) up to 27 days over several visits.

Eligibility

Age range: 18–65 years
Sex: Female
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Are overtly healthy * Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²) Exclusion Criteria: * Have known allergies to imlunestrant (freebase) or or imlunestrant tosylate or omeprazole * Have significant history or clinical manifestation of an of the following disorders: metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric * Have a chronic history of liver disease, or known hepatic or biliary abnormalities * Have…

A Phase 1, Open-Label, 4-Part Study to Investigate the Relative Bioavailability and Bioequivalence of Imlunestrant (LY3484356) Test and Reference Formulations and the Effects of Food and Omeprazole on the Pharmacokinetics of Imlunestrant, in Healthy Female Participants of Non-Childbearing Potential

Summary

Eligibility

Interventions

Locations (5)