A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06342596
• Other study ID #: 18597
• Secondary ID: J2O-MC-EKBD
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-LY3473329
Administered orally
• [14C]-LY3473329
Administered IV
• LY3473329
Administered orally

Locations

Country	Name	City	State
United Kingdom	Fortrea Clinical Research Unit	Holbeck	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Day 1 up to Day 29 post dose
Primary	Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Day 1 up to Day 29 post dose
Primary	Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329	Part 2: PK: F of LY3473329	Day 1 up to Day 9 post dose
Secondary	Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329	Part 1: PK: AUC(0-tlast) of LY3473329	Day 1 up to Day 29 post dose
Secondary	Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity	Part 1: PK: AUC(0-tlast) of Total Radioactivity	Day 1 up to Day 29 post dose
Secondary	Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-8) of LY3473329	Part 1: PK: AUC(0-8) of LY3473329	Day 1 up to Day 29 post dose
Secondary	Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-8) of Total Radioactivity	Part 1: PK: AUC(0-8) of Total Radioactivity	Day 1 up to Day 29 post dose
Secondary	Part 1: PK: Maximum Concentration (Cmax) of LY3473329	Part 1: PK: Cmax of LY3473329	Day 1 up to Day 29 post dose
Secondary	Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity	Part 1: PK: Cmax of Total Radioactivity	Day 1 up to Day 29 post dose
Secondary	Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Day 1 up to Day 29 post dose
Secondary	Part 1: Total Number of Metabolites of LY3473329	Part 1: Total Number of Metabolites of LY3473329	Day 1 up to Day 29 post dose
Secondary	Part 2: PK: AUC (0-8) of LY3473329	Part 2: PK: AUC (0-8) of LY3473329	Day 1 up to Day 9 post dose
Secondary	Part 2: PK: AUC (0-8) of [14C]-LY3473329	Part 2: PK: AUC (0-8) of [14C]-LY3473329	Day 1 up to Day 9 post dose
Secondary	Part 2: PK: AUC (0-8) of Total Radioactivity	Part 2: PK: AUC (0-8) of Total Radioactivity	Day 1 up to Day 9 post dose
Secondary	Part 2: PK: Cmax of LY3473329	Part 2: PK: Cmax of LY3473329	Day 1 up to Day 9 post dose
Secondary	Part 2: PK: Cmax of [14C]-LY3473329	Part 2: PK: Cmax of [14C]-LY3473329	Day 1 up to Day 9 post dose
Secondary	Part 2: PK: Cmax of Total Radioactivity	Part 2: PK: Cmax of Total Radioactivity	Day 1 up to Day 9 post dose
Secondary	Part 2: Total Radioactivity Recovered in Urine and Feces	Part 2: Total Radioactivity Recovered in Urine and Feces	Day 1 up to Day 9 post dose