A Study of [14C]-LY4065967 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2025-08-16

Brief Summary

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The purpose of this study is to investigate the absorption, metabolism, excretion, and bioavailability of LY4065967 in healthy male participants. This is a 2-part study. The study will last about 58 days for participants in Part 1 and about 60 days for participants in Part 2.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C]-LY4065967 Part 1

A single dose containing \[14C\]-LY4065967.

Group Type EXPERIMENTAL

[14C]-LY4065967 Oral

Intervention Type RADIATION

Oral dose

LY4065967 Part 2

A single dose of LY4065967 followed by a single dose of \[14C\]-LY4065967.

Group Type EXPERIMENTAL

LY4065967

Intervention Type DRUG

Oral dose

[14C]-LY4065967 IV

Intervention Type RADIATION

IV dose

Interventions

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LY4065967

Oral dose

Intervention Type DRUG

[14C]-LY4065967 Oral

Oral dose

Intervention Type RADIATION

[14C]-LY4065967 IV

IV dose

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiograms (ECGs).
* Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Have venous access sufficient to allow for blood sampling.
* Currently have a minimum of 1 bowel movement per day.
* Have a body mass index within 18.0 to 35.0 kg/m², inclusive
* Assigned male at birth

Exclusion Criteria

* Have significant previous or current history of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, neurological, thromboembolism, or bleeding disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study intervention; or of interfering with the interpretation of data.
* Have a significant history of or current psychiatric disorders.
* Have history of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs. Uncomplicated appendectomy, uncomplicated cholecystectomy, and hernia repair will be allowed.
* Have a history of significant chronic constipation or have had acute constipation within 3 weeks prior to check-in.
* Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG analysis.
* Have an abnormal blood pressure or pulse rate as determined by the investigator.
* Have known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy.
* Are currently enrolled in or have participated within the last 3 months in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. If the previous investigational product has a long t1/2, 5 half-lives or 30 days, whichever is longer, should have passed prior to check-in.
* Have previously completed or withdrawn from this study or any other study investigating LY4065967 and have previously received LY4065967.
* Part 2 only: Total \[14C\]-radioactivity measured in plasma exceeding 2.5 × the standard biological carbon ratio, 50 pMC when analyzed with carbon carrier radiodilution or 250 pMC when analyzed without carbon carrier dilution.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes