Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.
Interventions
DRUGLY3537982
Administered orally.
DRUGItraconazole
Administered orally.
DRUGCarbamazepine
Administered orally.
Sponsors
Loxo Oncology, Inc.
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease * Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Exclusion criteria
* Females who are lactating or of childbearing potential * Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | PK: Cmax of LY3537982 administered with or without itraconazole |
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | PK: AUC\[0-inf\] of LY3537982 administered with or without itraconazole |
| PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 | PK: AUClast of LY3537982 administered with or without itraconazole |
| PK: Cmax of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 | PK: Cmax of LY3537982 administered with or without carbamazepine |
| PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 | PK: AUC\[0-inf\] of LY3537982 administered with or without carbamazepine |
| PK: AUClast of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 | PK: AUClast of LY3537982 administered with or without carbamazepine |
Countries
United States
Outcome results
None listed