A Study of LY4268989 (MORF-057) in Healthy Participants
- 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
- Short title
- A Study of LY4268989 (MORF-057) in Healthy Participants
- Official title
- A Phase 1 Study to Further Investigate the Pharmacokinetics, Safety and Tolerability, Food Effect and Drug-Drug Interaction of LY4268989 (MORF-057) in Healthy Participants
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-02-17
- First posted
- 2025-05-09
- Registry last updated
- 2026-03-27
- Primary completion date
- 2026-02-17
- Start date
- 2025-05-01
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06964776
- ClinicalTrials.gov ID
- NCT06964776
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- Double masking
- Masking description
- Cohort 1, 4 and 5 are blinded while Cohort 2, 3, 6, 7, and 8 are open label.
- Masked roles
- Participants, Investigators
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)
Timeframe: Day 1 to Day 17
PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: Day 1 to Day 13
PK: AUC of LY4268989 (Cohort 2)
Timeframe: Day 1 to Day 13
PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: Day 1 to Day 7
PK: AUC of LY4268989 (Cohort 6)
Timeframe: Day 1 to Day 7
PK: Cmax of LY4268989 (Cohort 7)
Timeframe: Day 1 to Day 12
PK: AUC of LY4268989 (Cohort 7)
Timeframe: Day 1 to Day 12
PK: Cmax of LY4268989 (Cohort 4)
Timeframe: Day 1 to Day 4
PK: AUC of LY4268989 (Cohort 4)
Timeframe: Day 1 to Day 4
PK: Cmax of LY4268989 (Cohort 3)
Timeframe: Time Frame: Day 6 to Day 15
PK: AUC of LY4268989 (Cohort 3)
Timeframe: Time Frame: Day 6 to Day 15
PK: Cmax of LY4268989 (Cohort 8)
Timeframe: Time Frame: Day 3 and Day 10
PK: AUC of LY4268989 (Cohort 8)
Timeframe: Time Frame: Day 3 and Day 10
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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.
- 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
- CenExel ACTAnaheim, United States
Other registry identifiers
- J6E-MC-KWAC