About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
LY5625573
DrugAdministered orally as tablet
Midazolam
DrugAdministered orally
Placebo
DrugAdministered orally as tablet
Treatment groups
10
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: