Clinical trial NCT06901336: A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants
Official title: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-STX-478 Following Single-Dose Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion
timeFrame: Baseline, Up to Day 29
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478
timeFrame: Predose up to Day 29 Post Dose
measure: PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478
timeFrame: Predose up to Day 29 Post Dose
measure: Total Radioactivity Recovered in Urine and Feces
timeFrame: Predose up to Day 29 Post Dose
measure: Total Number of Metabolites and Identification of Metabolites of STX-478 in Plasma, Urine, and Feces
timeFrame: Predose up to Day 29 Post Dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron Clinical Pharmacology Center Inc
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: