Healthy
Conditions
Brief summary
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Cohort 1, 4 and 5 are blinded while Cohort 2, 3, 6, 7, and 8 are open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs. * Cohort 5 includes Japanese participants. To qualify, the participants must be first-generation Japanese in the US, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan. * Cohort 5 includes Chinese participants. To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China. * Have a body mass index within the range of 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, or alternative medicines, within 14 days or 5 half-lives (whichever is longer), prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5) | Day 1 to Day 17 | — |
| PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5) | Day 1 to Day 17 | — |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5) | Baseline to Study Completion (Up to Day 17) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module |
| Number of Participants with TEAEs and SAEs (Cohort 4) | Baseline to Study Completion (Up to Period 4, Day 4) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module |
| PK: Cmax of LY4268989 (Cohort 2) | Day 1 to Day 13 | — |
| PK: AUC of LY4268989 (Cohort 2) | Day 1 to Day 13 | — |
| PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3) | Day 1 to Day 17 | PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989 |
| PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8) | Day 3 and Day 11 | PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989 |
| PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3) | Day 1 to Day 17 | PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989 |
| PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8) | Day 3 to Day 11 | PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989 |
| PK: Cmax of LY4268989 (Cohort 6) | Day 1 to Day 7 | — |
| PK: AUC of LY4268989 (Cohort 6) | Day 1 to Day 7 | — |
| PK: Cmax of LY4268989 (Cohort 7) | Day 1 to Day 12 | — |
| PK: AUC of LY4268989 (Cohort 7) | Day 1 to Day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: Cmax of LY4268989 (Cohort 4) | Day 1 to Day 4 |
| PK: AUC of LY4268989 (Cohort 4) | Day 1 to Day 4 |
| PK: Cmax of LY4268989 (Cohort 3) | Time Frame: Day 6 to Day 15 |
| PK: AUC of LY4268989 (Cohort 3) | Time Frame: Day 6 to Day 15 |
| PK: Cmax of LY4268989 (Cohort 8) | Time Frame: Day 3 and Day 10 |
| PK: AUC of LY4268989 (Cohort 8) | Time Frame: Day 3 and Day 10 |
Countries
United States
Contacts
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