Phase 1
N=6
A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02917733 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 90.2 percentage of administered radioactivity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3039478 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
90.2 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3039478 |
2570 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity |
26100 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478 |
517 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity |
1060 | — |
| SECONDARY Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces |
8; 10; 3 | — |
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.
Eligibility Criteria
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- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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
Data sourced from ClinicalTrials.gov (NCT02917733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.