Healthy
Conditions
Brief summary
The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.
Interventions
DRUGLY3154207 Capsule
Administered orally as capsule
DRUGLY3154207 Tablet
Administered orally as tablet
DRUGPlacebo
Administered orally as tablet
Administered orally as tablet
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
The capsule versus tablet formulation comparison will be open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²) * Have clinical laboratory test results within acceptable range for the population
Exclusion criteria
* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study * Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study * Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study * Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of \< 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline up to 11 weeks | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Blood Pressure (BP) | Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole | BP measured by ambulatory blood pressure monitoring (ABPM) |
| Change from Baseline in Pulse Rate (PR) | Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole | PR measured by ABPM |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207 | Baseline up to 48 hours postdose | PK: Cmax of LY3154207 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207 | Baseline up to 48 hours postdose | PK: AUC(0-tlast) of LY3154207 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207 | Baseline up to 48 hours postdose | PK: AUC(0-inf) of LY3154207 |
Countries
United States
Outcome results
None listed