Clinical trial NCT06049108: A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male Participants
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-LY3871801 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_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 (LY3871801), 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 up to approximately 9 weeks including the screening period.


Eligibility criteria: Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds, or any components of the formulation, or a history of significant atopy
* Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call
* Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in

Primary outcomes:
measure: Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 7 post dose
measure: Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 7 post dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801
timeFrame: Predose up to Day 7 post dose
measure: PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood
timeFrame: Predose up to Day 7 post dose
measure: PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801
timeFrame: Predose up to Day 7 post dose
measure: PK: Cmax of Total Radioactivity
timeFrame: Predose up to Day 7 post dose
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air
timeFrame: Predose up to Day 7 post dose
measure: Total Number of Metabolites of LY3871801
timeFrame: Predose up to Day 7 post dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
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: