A Phase 1 interventional study of LY4355756 and LY4355756 in Healthy, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purpose of the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants.
There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.
Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB)
Exclusion Criteria:
Have a diagnosis or history of malignancy within 5 years prior to screening
Exceptions:
Single-ascending dose (SAD) of LY4355756 administered orally
Drug: LY4355756
Multiple-ascending doses (MAD) of LY4355756 administered orally
Drug: LY4355756
Single dose of LY4355756 administered orally in each of three study periods
Drug: LY4355756
LY4355756 and midazolam co-administered orally
Drug: LY4355756 · Drug: Midazolam
Midazolam administered orally
Drug: Midazolam
Administered orally as capsule
Administered orally as tablet
Administered orally as liquid
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to the Safety Follow up Visit (6 months)
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to the Safety Follow up Visit (6 months)
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756
Time frame: Baseline up to Day 18
PK: Maximum Plasma Concentration (Cmax) of LY4355756
Time frame: Baseline up to Day 18
PK: AUC of Midazolam
Time frame: Baseline up to Day 14
PK: Cmax of Midazolam
Time frame: Baseline up to Day 14
Plan to share: No
No publications or documents are linked to this record.
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Eli Lilly and Company