A Study of LY2801653 in Healthy Participants

NCT01981408 | Completed Phase 1

• 2 other identifiers: 15283I3O-EW-JSBC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

[^14C]-LY2801653

EXPERIMENTAL

Single oral dose of LY2801653 containing 100 micro curies of radioactivity

Drug: [^14C]-LY2801653

Interventions

[^14C]-LY2801653 DRUG

Administered orally

[^14C]-LY2801653

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)