Healthy
Conditions
Brief summary
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.
Interventions
DRUGLY4268989
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 | Day 1 to Day 18 |
| PK: Area Under the Concentration Curve (AUC) of LY4268989 | Day 1 to Day 18 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed