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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Radiation: [14C]-LY4065967 Oral; Drug: LY4065967; Radiation: [14C]-LY4065967 IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07039045

J4X-MC-LWCB (Other Identifier)

27203

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

[14C]-LY4065967 Part 1

Experimental group

Description:

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

Treatment:

Radiation: [14C]-LY4065967 Oral

LY4065967 Part 2

Experimental group

Description:

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

Treatment:

Radiation: [14C]-LY4065967 IV

Drug: LY4065967