Healthy
Conditions
Brief summary
The purpose of the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants. There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.
Interventions
DRUGLY4355756
Administered orally as capsule
DRUGMidazolam
Administered orally as liquid
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Parts A and B are Double-Blinded, Parts C and D are Open-Label
Intervention model description
Parts A and B are parallel; Part C is crossover; Part D is sequential
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECGs), and vital signs * Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive) * Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion criteria
* Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders, or abnormal laboratory values at screening * Have an abnormality in 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participating in the study or may confound ECG data analysis * Have a diagnosis or history of malignancy within 5 years prior to screening * Exceptions: * basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening * Have had breast cancer within the past 10 years * Have a history or presence of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food * Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment * Have a current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) * Have received any live (including attenuated live vaccines), non-live, or inactivated vaccine(s) within less than 4 weeks before randomization or intend to receive them during the study * Are individuals AFAB who, during the study, are pregnant, have positive pregnancy testing, intend to become pregnant, are lactating, or intend to breastfeed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to the Safety Follow up Visit (6 months) |
| Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to the Safety Follow up Visit (6 months) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756 | Baseline up to Day 18 |
| PK: Maximum Plasma Concentration (Cmax) of LY4355756 | Baseline up to Day 18 |
| PK: AUC of Midazolam | Baseline up to Day 14 |
| PK: Cmax of Midazolam | Baseline up to Day 14 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
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