NCT06342596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

February 26, 2024

Last Update Submit

May 29, 2024

Conditions

Healthy

Keywords

RadioactiveADMEDispositionBioavailability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329

    Part 2: PK: F of LY3473329

    Day 1 up to Day 9 post dose

Secondary Outcomes (15)

  • Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329

    Day 1 up to Day 29 post dose

  • Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity

    Day 1 up to Day 29 post dose

  • Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329

    Day 1 up to Day 29 post dose

  • Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity

    Day 1 up to Day 29 post dose

  • Part 1: PK: Maximum Concentration (Cmax) of LY3473329

    Day 1 up to Day 29 post dose

  • +10 more secondary outcomes

Study Arms (2)

[14C]-LY3473329 (Part 1)

EXPERIMENTAL

Single dose of \[¹⁴C\]-LY3473329 administered orally

Drug: [14C]-LY3473329

LY3473329 + [14C]-LY3473329 (Part 2)

EXPERIMENTAL

Single dose of LY3473329 administered orally followed by a single dose of \[¹⁴C\]-LY3473329 administered intravenously (IV)

Drug: [14C]-LY3473329Drug: LY3473329

Interventions

[14C]-LY3473329DRUG

Administered orally

[14C]-LY3473329 (Part 1)
LY3473329DRUG

Administered orally

LY3473329 + [14C]-LY3473329 (Part 2)

Eligibility Criteria

Age35 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortrea Clinical Research Unit

Holbeck, Leeds, LS11 9EH, United Kingdom

Location

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

April 2, 2024

Study Start

March 5, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)