A Study of LY2801653 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981408
• Other study ID #: 15283
• Secondary ID: I3O-EW-JSBC
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2013
• Last updated: January 8, 2014
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [^14C]-LY2801653
Administered orally

Locations

Country	Name	City	State
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.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plasma Pharmacokinetics of LY2801653 and Radioactivity Maximum Observed Concentration (Cmax)		Pre-dose up to 14 days post dose	No
Secondary	Plasma Pharmacokinetics of LY2801653 and Radioactivity Time of Maximum Concentration (tmax)		Pre-dose up to 14 days post dose	No
Secondary	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	No
Secondary	Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Urine and Feces		Pre-dose up to 14 days post dose	No
Secondary	Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Plasma		Pre-dose up to 14 days post dose	No