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A Study of LY4515100 in Healthy Participants
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2026-01-15
Completion Date
2027-03
Last Updated
2026-07-29
Healthy Volunteers
Yes
Conditions
Interventions
LY4515100 via SAD
given orally
LY4515100 via MAD
given orally
LY4515100
given orally
Itraconazole
given orally
Caffeine
given orally
Digoxin
given orally
Iohexol
given IV
Metformin
given orally
Rosuvastatin
given orally
Placebo
given orally
Locations (1)
Fortrea Clinical Research Unit
Dallas, Texas, United States