Clinical trial NCT06342596: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants
Official title: A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Radioactive
ADME
Disposition
Bioavailability
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 16
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), 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 when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.


Eligibility criteria: Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.0 to 35.0 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 LY3473329, related compounds, or any components of the formulation, or history of significant atopy
* Have a history of constipation or have had acute constipation within 3 weeks prior to check-in
* Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in
* Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes
* Have participated, within the last 3 months, in a clinical study involving an investigational product

Primary outcomes:
measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Day 1 up to Day 29 post dose
measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329
timeFrame: Day 1 up to Day 9 post dose
Secondary outcomes:
measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
timeFrame: Day 1 up to Day 29 post dose
measure: Part 1: Total Number of Metabolites of LY3473329
timeFrame: Day 1 up to Day 29 post dose
measure: Part 2: PK: AUC (0-∞) of LY3473329
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: PK: AUC (0-∞) of Total Radioactivity
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: PK: Cmax of LY3473329
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: PK: Cmax of [14C]-LY3473329
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: PK: Cmax of Total Radioactivity
timeFrame: Day 1 up to Day 9 post dose
measure: Part 2: Total Radioactivity Recovered in Urine and Feces
timeFrame: Day 1 up to Day 9 post dose
Other outcomes:
Locations:
city: Holbeck
country: United Kingdom
facility: Fortrea Clinical Research Unit
state: Leeds
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: