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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3039478

• Registration Number: NCT02917733
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Primary Completion: 2016-11
• Study Completion: 2016-11-01
• Results First Submitted: 2025-06-20
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Results First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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• Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiolabelled LY3039478	LY3039478	Single dose of radiolabelled LY3039478 administered orally.

Primary Outcome Measures

Name	Time	Method
Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	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	To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478	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	The AUC\[0-inf\]) for plasma LY3039478 was evaluated by using a combination of the linear and logarithmic trapezoidal methods (linear-log trapezoidal rule).
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity	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	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).
Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478	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	The Cmax of LY3039478 was evaluated.
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity	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	Cmax of total plasma radioactivity was evaluated.
Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces	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.	Following oral administration, radio high performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) profiles were obtained from analysis of plasma, urine and feces.

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States