Healthy
Conditions
Keywords
Cholestyramine, LOXO-783
Brief summary
The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.
Interventions
DRUGLOXO-783
Administered orally.
DRUGCholestyramine
Administered orally.
Sponsors
Loxo Oncology, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 LOXO-783 | Predose on Day 1 upto 96 hours postdose of each treatment period | PK: Cmax of LOXO-783 |
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783 | Predose on Day 1 upto 96 hours postdose of each treatment period | PK: AUC(0-inf) of LOXO-783 |
Countries
United States
Outcome results
None listed