A Study of LY2801653 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [^14C]-LY2801653

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981408

I3O-EW-JSBC (Other Identifier)

15283

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 1 patient group

[^14C]-LY2801653

Experimental group

Description:

Single oral dose of LY2801653 containing 100 micro curies of radioactivity

Treatment:

Drug: [^14C]-LY2801653