A Study of LY2940680 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: [^14C]-LY2940680

Registration Number: NCT01746745

Lead Sponsor: Eli Lilly and Company

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[^14C]-LY2940680	[^14C]-LY2940680	Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 (\[\^14C\]-LY2940680)

Primary Outcome Measures

Name	Time	Method
Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to 14 days postdose. Samples collected at 24-h intervals.	The percentage of the total radioactive dose administered that was excreted in feces = \[(amount of radioactivity recovered in feces)/(radioactive dose administered)\]\*100.
Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	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.	The percentage of the total radioactive dose administered that was excreted in urine=\[(amount of radioactivity recovered in urine)/(radioactive dose administered)\]\*100.

Secondary Outcome Measures

Name	Time	Method
Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (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	The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported.
PK of Radioactivity: 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.	AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms\hour equivalents per gram (ng\h Eq/g).
Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine	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 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.
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.
Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma	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 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.
Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces	Predose up to 8 days postdose. Samples collected at 24-h intervals.	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.
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)	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.	The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood.

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.
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Madison, Wisconsin, United States