Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 (\[¹⁴C\]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and \[¹⁴C\]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.
Interventions
DRUG[¹⁴C]-LOXO-783
Administered orally
DRUGLOXO-783
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, ECGs, vital signs, and clinical laboratory evaluations 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 |
|---|---|---|
| PK: Absolute Bioavailability (F) of LOXO-783 | Predose on day 1 up to postdose on day 9 (Part 2) | PK: F of LOXO-783 |
| 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 |
Countries
United States
Outcome results
None listed