A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [^14C]-LY2835219

• Registration Number: NCT01913314
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This type of study is called a radiolabeled study. For this study, LY2835219 (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 understand how the drug appears in the blood, urine, and stool after it is administered.

In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.

This study will last about 3 weeks for each participant, not including screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study Start: 2013-08
• Study First Posted: 2013-08-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2017-10-27
• Results First Submitted QC: 2017-10-27
• Results First Posted: 2018-08-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

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

Inclusion Criteria

• Overtly healthy male or female participants as determined by medical history and physical examination
• Male participants will be sterile
• Female participants will be surgically sterile or postmenopausal
• Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m^2)
• Have venous access sufficient to allow for blood sampling

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Exclusion Criteria

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[^14C]-LY2835219	[^14C]-LY2835219	Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) \[\^14C\] labeled drug

Primary Outcome Measures

Name	Time	Method
Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose	The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) \* 100.

Secondary Outcome Measures

Name	Time	Method
Plasma PK of Radioactivity: Cmax	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax)	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Plasma PK of Radioactivity: AUC(0-∞)	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces	Predose through 216 h postdose; Fecal samples collected at 24-h intervals	The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) \* 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.
Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose	The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = \[AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity\] \* 100.
Plasma PK of Radioactivity: AUC(0 to Tlast)	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose	The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq\*h/g).
Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)]	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose
Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)]	Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Madison, Wisconsin, United States