A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants

Eli Lilly and Company6 enrolled

Overview

This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon \[¹⁴C\]. \[¹⁴C\] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LY3039478DRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²), inclusive Exclusion Criteria: * Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product * Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy * Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) * Have participated in a \[¹⁴C\] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous \[¹⁴C\]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: less than 5000 millirem (mrem)/year whole body annual exposure

Locations (1)

Covance Clinical Research Inc

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478.

Time frame: Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, and 312 hours postdose

Secondary Outcomes

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478

The AUC\[0-inf\]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).

Time frame: Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity

The AUC\[0-inf\]) for total plasma radioactivity was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).

Time frame: Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478

The Cmax of LY3039478 was evaluated.

Time frame: Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity

Cmax of total plasma radioactivity was evaluated.

Time frame: Predose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Data from ClinicalTrials.gov

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