A Study of LY4268989 (MORF-057) in Healthy Participants
- Registration Number
- NCT06964776
- Lead Sponsor
- Eli Lilly and Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 66
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 the participants must be considered as native Chinese, defined as all the participant's biological grandparents being of Chinese origin.
- Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kilogram/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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY4268989 or Placebo Cohort 1 (Blinded) LY4268989 Participants will receive LY4268989 orally or placebo single dose followed by BID administration LY4268989 or Placebo Cohort 1 (Blinded) Placebo Participants will receive LY4268989 orally or placebo single dose followed by BID administration LY4268989 Cohort 2 (Open-Label) LY4268989 Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state LY4268989 Cohort 3 (Open-Label) LY4268989 Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). LY4268989 Cohort 3 (Open-Label) Midazolam Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). LY4268989 or Placebo Cohort 4 (Blinded) LY4268989 Participants will receive single escalating doses of LY4268989 orally or placebo LY4268989 or Placebo Cohort 4 (Blinded) Placebo Participants will receive single escalating doses of LY4268989 orally or placebo LY4268989 Cohort 5 (Blinded) LY4268989 Participants will receive multiple doses of LY4268989 orally or placebo LY4268989 Cohort 5 (Blinded) Placebo Participants will receive multiple doses of LY4268989 orally or placebo
- Primary Outcome Measures
Name Time Method PK: AUC of LY4268989 (Cohort 2) Day 1 to Day 13 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: 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
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
- Secondary Outcome Measures
Name Time Method PK: Cmax of LY4268989 (Cohort 4) Day 1 to Day 4 PK: AUC of LY4268989 (Cohort 4) Day 1 to Day 4
Trial Locations
- Locations (1)
CenExel ACT
🇺🇸Anaheim, California, United States