A Study of LY2940680 in Healthy Participants

Disposition of [14C]-LY2940680 Following Oral Administration in Healthy Subjects

This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [^14C]-LY2940680

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
• Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive

Exclusion Criteria:

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
• Have donated blood of more than 500 milliliters (mL) within the last month
• Have participated in a [^14C]-study within the last 6 months prior to admission for this study
• Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
• Have a pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [^14C]-LY2940680; Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 ([^14C]-LY2940680)	Drug: [^14C]-LY2940680; Administered as solution by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	The percentage of the total radioactive dose administered that was excreted in feces = [(amount of radioactivity recovered in feces)/(radioactive dose administered)]*100.	Predose up to 14 days postdose. Samples collected at 24-h intervals.
Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	The percentage of the total radioactive dose administered that was excreted in urine=[(amount of radioactivity recovered in urine)/(radioactive dose administered)]*100.	Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax)	The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported.	Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter
PK of Radioactivity: Cmax		Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax)	The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood.	Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)]		Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
PK of Radioactivity: AUC(0 to Tlast)	AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms*hour equivalents per gram (ng*h Eq/g).	Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.
Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma	Relative abundance was expressed and calculated as the percentage of plasma sample radioactivity=[(radioactivity in peak)/(radioactivity in sample)]*100. Metabolites with a relative abundance ≤6% are not reported.	Day 1 up to 3 days postdose. Samples collected at 2, 3, 4, 6, and 8 h postdose on Day 1 and every 24 h thereafter.
Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine	Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.	Predose up to 4 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.
Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces	Relative abundance was expressed and calculated as the percentage of the administered dose excreted in feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.	Predose up to 8 days postdose. Samples collected at 24-h intervals.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14892; I4J-MC-HHBF (Other Identifier: Eli Lilly and Company)