LY4178256 safety and pharmacokinetics in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial investigates the safety, tolerability, and pharmacokinetics of LY4178256 compared with placebo in healthy volunteers. Participants will undergo screening and then about seven months of follow-up with 7 or 12 study visits depending on treatment assignment. Blood tests will measure blood levels and elimination of the drug, while safety assessments will monitor side effects and vital signs. The study excludes individuals with significant health conditions or abnormal screening results to minimize risk and interpret pharmacokinetic data clearly.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures.
* Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²)
* Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.

Exclusion Criteria:

* Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.
* Have abnormal blood pressure
* Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (\>450 msec) for males, or \>470 msec for females.
* Regularly use known drugs of abuse or with positive drug results (within the past 3 months).
* Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in.
* Have hemoglobin level less than 12 grams per deciliter (\<12 g/dL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (\<30 ng/mL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.
* Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.
* Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR\<60mL/min/1.73 m ²)).

Where it's running

• Icon
  Salt Lake City, Utah, United States Recruiting
• Collaborative Neuroscience Network - CNS
  Los Alamitos, California, United States Not yet recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.