Clinical trial NCT02917733: A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants
Official title: Disposition of [¹⁴C₂]-Labeled LY3039478 Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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* Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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

Primary outcomes:
measure: Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to 168 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3039478
timeFrame: Predose through 168 hours postdose
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity
timeFrame: Predose through 168 hours postdose
measure: Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478
timeFrame: Predose through 168 hours postdose
measure: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity
timeFrame: Predose through 168 hours postdose
measure: Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces
timeFrame: Predose through 168 hours postdose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: