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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
144
CenExel ACT
Anaheim, California, United States
RECRUITINGPharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)
Time frame: Day 1 to Day 17
PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)
Time frame: 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)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module
Time frame: Baseline to Study Completion (Up to Day 17)
Number of Participants with TEAEs and SAEs (Cohort 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
Time frame: Baseline to Study Completion (Up to Period 4, Day 4)
PK: Cmax of LY4268989 (Cohort 2)
Time frame: Day 1 to Day 13
PK: AUC of LY4268989 (Cohort 2)
Time frame: Day 1 to Day 13
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
Time frame: Day 1 to Day 17
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989
Time frame: Day 3 and Day 11
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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Administered intravenously (IV)
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
Time frame: Day 1 to Day 17
PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8)
PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989
Time frame: Day 3 to Day 11
PK: Cmax of LY4268989 (Cohort 6)
Time frame: Day 1 to Day 7
PK: AUC of LY4268989 (Cohort 6)
Time frame: Day 1 to Day 7
PK: Cmax of LY4268989 (Cohort 7)
Time frame: Day 1 to Day 12
PK: AUC of LY4268989 (Cohort 7)
Time frame: Day 1 to Day 12
PK: Cmax of LY4268989 (Cohort 4)
Time frame: Day 1 to Day 4
PK: AUC of LY4268989 (Cohort 4)
Time frame: Day 1 to Day 4
PK: Cmax of LY4268989 (Cohort 3)
Time frame: Time Frame: Day 6 to Day 15
PK: AUC of LY4268989 (Cohort 3)
Time frame: Time Frame: Day 6 to Day 15
PK: Cmax of LY4268989 (Cohort 8)
Time frame: Time Frame: Day 3 and Day 10
PK: AUC of LY4268989 (Cohort 8)
Time frame: Time Frame: Day 3 and Day 10