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

May 29, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • United Kingdom
    • Leeds
      • Holbeck, Leeds, United Kingdom, LS11 9EH
        • Fortrea Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]-LY3473329 (Part 1)
Single dose of [¹⁴C]-LY3473329 administered orally
Drug: [14C]-LY3473329
Administered orally
Drug: [14C]-LY3473329
Administered IV
Experimental: LY3473329 + [14C]-LY3473329 (Part 2)
Single dose of LY3473329 administered orally followed by a single dose of [¹⁴C]-LY3473329 administered intravenously (IV)
Drug: LY3473329
Administered orally
Drug: [14C]-LY3473329
Administered orally
Drug: [14C]-LY3473329
Administered IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame: Day 1 up to Day 29 post dose
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
Time Frame: 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
Day 1 up to Day 29 post dose
Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: F of LY3473329
Day 1 up to Day 9 post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: 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
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: 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
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: 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
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: AUC(0-∞) of Total Radioactivity
Day 1 up to Day 29 post dose
Part 1: PK: Maximum Concentration (Cmax) of LY3473329
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: Cmax of LY3473329
Day 1 up to Day 29 post dose
Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity
Time Frame: Day 1 up to Day 29 post dose
Part 1: PK: Cmax of Total Radioactivity
Day 1 up to Day 29 post dose
Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Time Frame: Day 1 up to Day 29 post dose
Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Day 1 up to Day 29 post dose
Part 1: Total Number of Metabolites of LY3473329
Time Frame: Day 1 up to Day 29 post dose
Part 1: Total Number of Metabolites of LY3473329
Day 1 up to Day 29 post dose
Part 2: PK: AUC (0-∞) of LY3473329
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of LY3473329
Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of [14C]-LY3473329
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of [14C]-LY3473329
Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of Total Radioactivity
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: AUC (0-∞) of Total Radioactivity
Day 1 up to Day 9 post dose
Part 2: PK: Cmax of LY3473329
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: Cmax of LY3473329
Day 1 up to Day 9 post dose
Part 2: PK: Cmax of [14C]-LY3473329
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: Cmax of [14C]-LY3473329
Day 1 up to Day 9 post dose
Part 2: PK: Cmax of Total Radioactivity
Time Frame: Day 1 up to Day 9 post dose
Part 2: PK: Cmax of Total Radioactivity
Day 1 up to Day 9 post dose
Part 2: Total Radioactivity Recovered in Urine and Feces
Time Frame: Day 1 up to Day 9 post dose
Part 2: Total Radioactivity Recovered in Urine and Feces
Day 1 up to Day 9 post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18597
  • J2O-MC-EKBD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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