Healthy
Conditions
Brief summary
The main purpose of this study is to conduct blood tests to measure how much STX-478 is in the bloodstream and how the body handles and eliminates it in healthy participants. This study will involve a single dose of 14C radiolabeled STX-478. This means that a radioactive tracer substance, C14, will be incorporated into the study drug STX-478 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 STX-478.
Interventions
DRUG[14C]-STX-478
oral administration
Sponsors
Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening. * Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antigen (HIV Ab/Ag). * Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and admission
Exclusion criteria
History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor * Any history of serious allergic/hypersensitivity reactions * History or presence of alcohol or drug abuse (self-reported) within 2 years prior to Screening. * Administration of any prescription or non-prescription drugs (including antacids; however, acetaminophen at a dose ≤ 1 g/day is permitted), herbal remedies or vitamin supplements from 28 days, or five half-lives, whichever is longer, prior to Admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion | Baseline, Up to Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478 | Predose up to Day 29 Post Dose |
| PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478 | Predose up to Day 29 Post Dose |
| Total Radioactivity Recovered in Urine and Feces | Predose up to Day 29 Post Dose |
| Total Number of Metabolites and Identification of Metabolites of STX-478 in Plasma, Urine, and Feces | Predose up to Day 29 Post Dose |
Countries
United States
Outcome results
None listed