Clinical trial NCT05749848: A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants
Official title: Open-Label Study to Assess the Disposition of [14C]-LY3372689 Following Oral Administration in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Radiolabeled Drug
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how much of the study drug (LY3372689), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.


Eligibility criteria: Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
* Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.

Exclusion Criteria:

* Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have evidence of significant active neuropsychiatric disease, as determined by the investigator
* Have participated in \>3 radiolabeled drug studies in the last 12 months

Primary outcomes:
measure: Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 17 post dose
measure: Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 17 post dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689
timeFrame: Predose up to Day 17 post dose
measure: PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689
timeFrame: Predose up to Day 17 post dose
measure: PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689
timeFrame: Predose up to Day 17 post dose
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
timeFrame: Predose up to Day 17 post dose
measure: Total Number of Metabolites of LY3372689
timeFrame: Predose up to 120 hour post dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: LabCorp CRU, Inc.
state: Wisconsin
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: