A Study of LY2940680 in Healthy Participants

NCT ID: NCT01746745

Last Updated: 2019-07-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[^14C]-LY2940680

Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 (\[\^14C\]-LY2940680)

Group Type EXPERIMENTAL

[^14C]-LY2940680

Intervention Type DRUG

Administered as solution by mouth

Interventions

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[^14C]-LY2940680

Administered as solution by mouth

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (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 milliliters (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 pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose
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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I4J-MC-HHBF

Identifier Type: OTHER

Identifier Source: secondary_id

14892

Identifier Type: -

Identifier Source: org_study_id

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