Healthy
Conditions
Brief summary
The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.
Interventions
DRUGLY3537982
Administered orally.
DRUG[¹⁴C]-LY3537982
Administered orally.
Sponsors
Loxo Oncology, Inc.
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination as assessed by the investigator. * Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²) * Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.
Exclusion criteria
* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor * Known ongoing alcohol and/or drug abuse within 2 years prior to Screening * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) | Predose on day 1 up to postdose on day 21 (Part 1) | PK: Feur |
| PK: Cumulative Feur | Predose on day 1 up to postdose on day 21 (Part 1) | PK: Cumulative Feur |
| PK: Fraction of Dose Excreted in Feces (Fefeces) | Predose on day 1 up to postdose on day 21 (Part 1) | PK: Fefeces |
| PK: Cumulative Fefeces | Predose on day 1 up to postdose on day 21 (Part 1) | PK: Cumulative Fefeces |
| PK: Fraction of Dose Excreted in Expired Air (Feair) | Predose on day 1 up to postdose on day 21 (Part 1) | PK: Feair |
| PK: Absolute Bioavailability (F) of LY3537982 | Predose on day 1 up to postdose on day 9 (Part 2) | PK: F of LY3537982 |
Countries
United States
Outcome results
None listed