A Study of LY4268989 (MORF 057) in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4268989.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of LY4268989 (MORF-057) in Healthy Participants
Overview
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
- Drug LY4268989
Administered orally
Primary outcome measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 [Time frame: Day 1 to Day 18]
- PK: Area Under the Concentration Curve (AUC) of LY4268989 [Time frame: Day 1 to Day 18]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Fortrea Clinical Research Unit — Daytona Beach
Identifiers
NCT: NCT07707375 · 27850 · J6E-MC-KWAP