A Study of LY2801653 in Healthy Participants

NCT ID: NCT01981408

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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[^14C]-LY2801653

Single oral dose of LY2801653 containing 100 micro curies of radioactivity

Group Type EXPERIMENTAL

[^14C]-LY2801653

Intervention Type DRUG

Administered orally

Interventions

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[^14C]-LY2801653

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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I3O-EW-JSBC

Identifier Type: OTHER

Identifier Source: secondary_id

15283

Identifier Type: -

Identifier Source: org_study_id

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