Healthy Participants
Conditions
Brief summary
This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study. Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed. Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207. Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant. Participants may only enroll in 1 of the 3 parts of the study.
Interventions
DRUGLY3154207
Administered orally
DRUGPlacebo
Administered orally
DRUGItraconazole
Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy males or females, as determined by medical history and physical examination * Female participants not of child-bearing potential * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * Have given written informed consent * Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2)
Exclusion criteria
* Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated * Part C only: Have known allergy or contraindications to itraconazole
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 | Up to 48 hours after administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207 | Predose through 48 hours after administration of study drug |
| Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207 | Predose through 48 hours after administration of study drug |
| Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207 | Predose through 48 hours after administration of study drug |
| Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole | Predose through 96 hours after administration of study drug |
| Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole | Predose through 96 hours after administration of study drug |
| Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207 | Predose through 48 hours after administration of study drug |
Countries
United States
Outcome results
None listed