Print

Purpose

The purpose of this study is to identify if two different tablets of LY4268989 (MORF 057) work similarly in healthy participants given different meals. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. There will be 18 inpatient stays at the clinical research unit (CRU). The study will last about 9 weeks.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs. - Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram/square meter (kg/m²), inclusive, at screening.

Exclusion Criteria

  • Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment. - Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data. - Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator. - Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, alternative medicines, or any medication known to be moderate to strong cytochrome P450 3A4 (CYP3A) inhibitors or inducers, or organic anion transporting polypeptide 1B1 (OATP1B) inhibitors, P-gp inhibitors, or medications that are narrow therapeutic index substrates for breast cancer resistance protein (BCRP) or P-gp within 14 days or 5 half lives, whichever is longer, prior to dosing, until the end of study assessments are complete.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4268989 Treatment A 		Participants will receive LY4268989 single dose T1 orally with high-fat meal
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Treatment B 		Participants will receive LY4268989 single dose T2 orally with high-fat meal
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Treatment C 		Participants will receive LY4268989 single dose T2 orally in a fasted state
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Treatment D 		Participants will receive LY4268989 single dose T3 orally with high-fat meal
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Treatment E 		Participants will receive LY4268989 single dose T3 orally in a fasted state
  • Drug: LY4268989
    Administered orally
Experimental
LY4268989 Treatment F 		Participants will receive LY4268989 single dose T1 orally in a fasted state
  • Drug: LY4268989
    Administered orally

Recruiting Locations

Fortrea Clinical Research Unit
Daytona Beach, Florida 32117
Contact:
386-366-6400

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.