NCT05749848

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2023

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 20, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

February 20, 2023

Last Update Submit

April 19, 2023

Conditions

Healthy

Keywords

Radiolabeled Drug

Outcome Measures

Primary Outcomes (2)

  • Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Predose up to Day 17 post dose

  • Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Predose up to Day 17 post dose

Secondary Outcomes (5)

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689

    Predose up to Day 17 post dose

  • PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689

    Predose up to Day 17 post dose

  • PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689

    Predose up to Day 17 post dose

  • Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

    Predose up to Day 17 post dose

  • Total Number of Metabolites of LY3372689

    Predose up to 120 hour post dose

Study Arms (1)

[¹⁴C]-LY3372689

EXPERIMENTAL

Single dose of \[¹⁴C\]-LY3372689 administered orally.

Drug: [¹⁴C]-LY3372689

Interventions

[¹⁴C]-LY3372689DRUG

Administered orally.

[¹⁴C]-LY3372689

Eligibility Criteria

Age18 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 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LabCorp CRU, Inc.

Madison, Wisconsin, 53704, United States

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
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

February 24, 2023

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)