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RECRUITING
NCT07339722
PHASE1

A Study of LY4515100 in Healthy Participants

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

DRUG

LY4515100 via SAD

given orally

DRUG

LY4515100 via MAD

given orally

DRUG

LY4515100

given orally

DRUG

Itraconazole

given orally

DRUG

Caffeine

given orally

DRUG

Digoxin

given orally

DRUG

Iohexol

given IV

DRUG

Metformin

given orally

DRUG

Rosuvastatin

given orally

DRUG

Placebo

given orally

Locations (1)

Fortrea Clinical Research Unit

Dallas, Texas, United States