A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants and an Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of LY4515100 and of LY4515100 on the Pharmacokinetics of CYP and Transporter Substrates in Healthy Participants
Eli Lilly and Company
Summary
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring. * Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive). * Individuals not of childbearing potential (INOCBP) may participate in this trial. Exclusion Criteria: * Have donated 500 milliliters (mL) of blood within 30 days prior to dosing. * Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous…