A Study of How the Body Breaks Down and Eliminates LY2623091

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LY2623091

• Registration Number: NCT02242981
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This type of study is called a radiolabeled study. For this study, LY2623091 (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 increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2020-06
• Results First Submitted: 2020-06-09
• Results First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Results First Posted: 2020-06-26
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

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

Inclusion Criteria

• Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
• With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY2623091	LY2623091	Single oral dose of LY2623091

Primary Outcome Measures

Name	Time	Method
Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)	Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.

Secondary Outcome Measures

Name	Time	Method
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces	Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091	Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091	Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091	Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

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