A Study of LY2801653 in Healthy Participants

Disposition of [^14C]-LY2801653 Following Oral Administration in Healthy Subjects

This type of study is called a radiolabeled study. For this study, LY2801653 (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 people. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [^14C]-LY2801653

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

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States
      • 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Generally healthy sterile male and female participants
• Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (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 milliliter (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 defecation pattern less than once per 2 days or acute constipation within 3 weeks of day before dosing

Study Plan

How is the study designed?

Design Details

• 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]-LY2801653; Single oral dose of LY2801653 containing 100 micro curies of radioactivity	Drug: [^14C]-LY2801653; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary and Fecal Excretion of LY2801653 Radioactivity over Time expressed as a Percentage of the Total Radioactive Dose Administered	Pre-dose up to 14 days post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Pharmacokinetics of LY2801653 and Radioactivity Maximum Observed Concentration (Cmax)	Pre-dose up to 14 days post dose
Plasma Pharmacokinetics of LY2801653 and Radioactivity Time of Maximum Concentration (tmax)	Pre-dose up to 14 days post dose
Plasma Pharmacokinetics of LY2801653 and Radioactivity Area Under The Concentration-time Curve from zero to the last timepoint with a measurable Concentration (AUC 0 to tlast)	Pre-dose up to 14 days post dose
Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Urine and Feces	Pre-dose up to 14 days post dose
Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Plasma	Pre-dose up to 14 days post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 15283; I3O-EW-JSBC (Other Identifier: Eli Lilly and Company)