Starting soon
Phase 1
A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein)
Condition(s) studied
C-Reactive Protein
Investigational drug(s) / intervention(s)
LY5625573: Administered orally as tablet
Midazolam: Administered orally
Placebo: Administered orally as tablet
Study summary
The purpose of this study is to learn if LY5625573 is safe and how well it is tolerated in healthy participants, including Japanese and Chinese participants, and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also look at how the body absorbs, breaks down, and clears the study drug (pharmacokinetics), how the study drug works in the body, and whether it interacts with certain other medications by affecting how the body processes them.
Participation in the study will last up to approximately 7 weeks for Part A and 8.5 weeks for Parts B, C, D, and E. For each participant there will be one stay at the clinical research unit (CRU) lasting 5 nights for Part A, 18 nights for Parts B and C, and 17 nights for Parts D and E.
Eligibility
Inclusion Criteria:
* 21 to 65 years of age, inclusive, at the time of signing the informed consent if enrolled in Singapore
* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have a hemoglobin level of at least 12.5 grams per deciliter (g/dL) for participants assigned male at birth (AMAB) and at least 11.4 g/dL for participants assigned female at birth (AFAB)
* Individuals AFAB who are individual not of childbearing potential (INOCBPs) may participate in this trial
Parts A, B, D, and E
* Have a body mass index (BMI) greater than or equal to (≥)18.5 and less than or equal to (≤) 32.0 kilograms per square meter (kg/m²)
* Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of ≥90 milliliter per minute per 1.73 square meters (mL)/minute/1.73 m² at screening
Part C
* Have a BMI ≥18.5 and \<40.0 kg/m²
* high-sensitivity C-reactive protein (hsCRP) ≥2 milligrams per liter (mg/L) and ≤15 mg/L at screening and Day -2 (as confirmed by local laboratory).
* Have an eGFR, using the CKD-EPI creatinine equation 2021, of ≥60 mL/minute/1.73 m² at screening
Part D
* To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan
Part E
* 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
Exclusion Criteria:
* History of active tuberculosis or presence of active or latent tuberculosis
* History or evidence of clinically significant opportunistic infection
* History of serious local infection (for example, cellulitis or abscess) or systemic infection within 90 days prior to screening
* Have any nonserious but active infections
* History of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection
* Have a 12-lead electrocardiogram (ECG) abnormality
* Clinically significant abnormal laboratory test results at screening, or positive serology test results for hepatitis B surface antigen, hepatitis B core total antibody, hepatitis C virus antibody, or human immunodeficiency virus antigen and antibody, or QuantiFERON®-TB test at screening
Parts A, C, D, and E
* History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232) or to any excipient in the formulation of LY5625573
Part B
* History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232), midazolam, or to any excipient in the formulation of LY5625573 or midazolam
Parts B, C, D, and E
* Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 90 days (at screening and/or Day -1 \[Day 2 for Part B\])
* Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire (at Day -1\[Day 2 for Part B\]
Primary outcome measure(s)
- 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 Follow up (Days 12 and 24)
- 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 Follow up (Days 12 and 24)
Trial sites (3)
| Facility | City | Region | Status |
| Collaborative Neuroscience Network - CNS |
Los Alamitos |
California |
|
| Fortrea Clinical Research Unit |
Dallas |
Texas |
|
| Lilly Centre for Clinical Pharmacology |
Singapore |
Singapore |
|
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